Drug Information Update · RECOMMENDATION: Compounding pharmacies should determine, based on the...

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Drug Information Update July 2018

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TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................................ 2 NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS .............................................. 3 NEW INDICATIONS (EXISTING DRUGS) ................................................................... 7

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ............................................. 8 STUDIES AND RECENT TOPICS .............................................................................. 12 RECALLS ............................................................................................................... 16 CURRENT DRUG SHORTAGES ............................................................................... 55


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

BUPRENORPHINE HCL/NALOXONE HCL 8mg-2mg DR. REDDY’S LAB SUBOXONE

ISOPROTERENOL HCL 0.2mg/mL CIPLA USA, INC. ISUPREL

HYDROXYPROGESTERONE CAPROAT/PF

250 MG/ 1 ML VIAL

AMER. REGENT PRASCO LABS MAKENA

BUDESONIDE 9 MG ACTAVIS UCERIS

KETOPROFEN 25 MG TEVA HERITAGE KETOPROFEN

COLESEVELAM HCL 3.65 GRAM GLENMARK PHARMA COLESEVELAM HCL


NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTINEOPLASTIC – MEK1 AND MEK2 KINASE

INHIBITORS MEKTOVI BINIMETINIB 15 MG New entity

MYDRIATICS TROPICAMIDE-

CYCLOPENTOLATE-PE

CYCLOPENTOLAT/ TROPIC/

PHENYLEPH

1%-1%-2.5% OPHTHALMIC

New dosage form code

ANTINEOPLASTIC – BRAF KINASE INHIBITORS BRAFTOVI ENCORAFENIB 50 MG New entity

ANTINEOPLASTIC – BRAF KINASE INHIBITORS BRAFTOVI ENCORAFENIB 75 MG New entity

INFLUENZA VIRUS VACCINES

FLUARIX QUAD 2018-2019

FLU VACC QS2018-19 (6MOS UP)/PF

60 MCG/0.5 ML New entity


FLULAVAL QUAD 2018-2019

FLU VACC QS2018-19 (6MOS UP)/PF



FLULAVAL QUAD 2018-2019

FLU VACC QUAD 2018-19 (6MOS UP)



FLUZONE QUAD 2018-2019

FLU VACC QUAD 2018-19 (6MOS UP)



FLUBLOK QUAD 2018-2019

FLU VACC QV 2018 (18YR UP)RCM/PF




FLU VACC QS2018-19 36 MOS UP/PF



FLUZONE QUAD PEDI 2018-2019

FLU VACC QS 2018 (6-35 MOS UP)/PF



FLUZONE HIGH-DOSE 2018-2019

FLU VACC TS2018-19 (65YR UP)/PF




FLU VACC QS2018-19 36 MOS UP/PF


SEDATIVE-HYPNOTICS, NON-BARBITURATE

MKO (MIDAZOLAM-KETAMINE-ONDAN)

MIDAZOLAM/ KETAMINE/

ONDANSETRON 3-25-2 MG New

combination

ANTIPSYCHOTICS, ARTP, D2 PARTIAL

AGONIST/5HT MIXED ARISTADA INITIO ARIPIPRAZOLE

LAUROXIL

675 MG/2.4 ML IM

INJECTION New entity

ANAGESICS, NARCOTICS ROXYBOND OXYCODONE HCL 15 MG New strength

ANALGESICS, NARCOTICS ROXYBOND OXYCODONE HCL 30MG New strength



FACTOR IX PREPARATIONS IDELVION FACTOR IX RECOM,

ALBUMIN FUSION 3500 (+/-) New strength

ERYTHROPOIESIS-STIMULATING AGENTS RETACRIT EPOETIN ALFA –

EPBX 40,000/ML New strength

SICKLE CELL ANEMIA AGENTS SIKLOS HYDROXYUREA 100 MG

New dosage form, new strength

GLUCOCORTICOIDS DEXONTO DEXAMETHASONE

SODIUM PHOSPHATE

0.004 New dosage form

OPHTHALMIC ANTI-INFLAMMATORY

IMMUNOMODULATOR- TYPE

CYCLOSPORINE IN KLARITY

CYCLOSPORINE/ CHONDROIT SULFA 0.1% - 0.25% New

combination

VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION IMVEXXY ESTRADIOL 10 MCG New dosage

form

VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION IMVEXXY ESTRADIOL 4 MCG

New dosage form, new strength

MIOTICS AND OTHER INTRAOCULAR PRESSURE

REDUCERS LATANOPROST LATANOPROST/PF 0.005% Preservative

free


REDUCERS

BRIMONIDINE – DORZOLAMIDE

BRIMONIDINE/ DORZOLAMIDE/PF 0.15% - 2% New

combination


REDUCERS

TIMOLOL – DORZOLAMIDE – LATANOPROST

TIMOLOL/ DORZOLAMIDE/

LATANO/PF

0.5% - 2% - 0.005%

New combination


REDUCERS

TIMOLOL – DORZOLAMIDE

DORZOLAMIDE/ TIMOLOL/PF 2% - 0.5% Preservative

free


REDUCERS

TIMOLOL – BRIMONIDIN – DORZOLAMIDE

TIMOLOL/ BRIMONIDIN/

DORZOLAM/PF

0.5% - 0.15% - 2%

New combination


REDUCERS

TIMOLOL – LATANOPROST

TIMOLOL MALEAE/ LATANOPROST/PF

0.5% - 0.005%

New combination


REDUCERS

TIMOLOL – BRIMONI – DORZOL –

LATANOP

TIMOLO/BRIMON/ DORZO/LATANOP/

PF 0.5% - 0.15% New

combination




REDUCERS DORZOLAMIDE DORZOLAMIDE

HCL/PF 0.02 Preservative free

EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS

GATIFLOXACIN – DEXAMETHASONE

GATIFLOXACIN/ DEXAMETHASONE 0.5% - 0.1% New

combination

EYE ANTI-INFLAMMATORY AGENTS

PREDNISOLONE ACETATE

PREDNISOLONE ACETATE/PF 0.01 Preservative

free

JANUS KINASE (JAK) INHIBITORS XELJANZ TOFACITINIB

CITRATE 10 MG New strength

DRUGS TO TREAT ERECTILE DYSFUNCTION IFE-BIMIX 30/1

PAPAVERINE/ PHENTOLAMINE/

WATER

30-1 MG/ML INTRACAVER. New strength

DRUGS TO TREAT ERECTILE DYSFUNCTION IFE-PG20 ALPROSTADIL IN

SODIUM CHLORIDE 20 MCG/ML

INTRACAVER. New strength

LEUKOCYTE (WBC) STIMULANTS FULPHILA PREGFILGRASTIM –

JMDB 6 MG/0.6 ML

SUB-Q

New entity; Neupogen biosimilar

NSAID AND TOPICAL IRRITANT COUNTER-

IRRITANT COMB

NUDROXIPAK I-800

IBUPROFEN/CAPSAI/M-

SAL/MENTHOL

800 MG-0.025%

Rx and OTC in kit

NSAIDS,COX-2 SEL.INHIB.(SYST)-

TOP.IRRITANT CTR-IRR NUDROXIPAK

IBUPROFEN/CAPSAI/M-

SAL/MENTHOL

200MG-.025%

Rx and OTC in kit

ANTIRETROVIRAL-NUCLEOSIDE,

NUCLEOTIDE, PROTEASE INH.

SYMTUZA DARUNAVIR/COB/EMTRI/TENOF ALAF 800-150 MG New

Combination

AMINOGLYCOSIDE ANTIBIOTICS ZEMDRI PLAZOMICIN

SULFATE 500MG/10M

L New Entity

INFLUENZA VIRUS VACCINES AFLURIA 2018-2019 FLU VACCINE

TS2018-19(5 YR UP) 45MCG/.5ML New Entity


AFLURIA QUAD 2018-2019

FLU VACC QUAD 2018-19(5 YR UP) 60MCG/.5ML New Entity


AFLURIA QUAD 2018-2019

FLU VACC QUAD 2018(5 YR UP)/PF 60MCG/.5ML New Entity

INFLUENZA VIRUS VACCINES AFLURIA 2018-2019

FLU VACCIN TS2018-19 5YR

UP/PF 45MCG/.5ML New Entity



INFLUENZA VIRUS VACCINES FLUAD 2018-2019

FLU VACC TS2018(65UP)/MF5

9C/PF 45MCG/.5ML New Entity


NEW INDICATIONS (EXISTING DRUGS) None


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections [Posted 06/14/2018] ISSUE: At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown. BACKGROUND: As part of its investigation into these adverse events, FDA collected and tested samples of Guardian’s product to identify and quantify the substances contained therein. FDA also prepared and tested in-house samples to assess the impact of autoclaving and sonication, which were used by Guardian during its compounding process, on the stability of the drug product. Below is a description of the test results and the agency’s analysis of those results. RECOMMENDATION: Compounding pharmacies should determine, based on the route of administration and the organ or tissue involved, whether the excipients are safe in the amount that will be present in the administered dose. One way to accomplish this is to use an excipient in an amount where scientific data support its safety, such as data supporting FDA approval of a comparable drug product with a similar concentration of the excipient. Compounding pharmacies also should consider whether the compounding process will generate degradants of such ingredients. Because compounded products are not evaluated by FDA for safety, effectiveness, or quality, health professionals should consult the compounding pharmacy about the safety information related to the excipients in the compounded products they plan to inject into their patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: •Complete and submit the report Online: www.fda.gov/MedWatch/report •Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA)


Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

[Posted 06/29/2018]

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

Risk Statement: In the event that 5mL rather than the intended 3mL is administered to a patient, adverse events from Neostigmine Methylsulfate overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, to Cholinergic Crisis resulting in death. To date, Fagron has not received any reports of adverse events or injuries related to this recall.

Neostigmine Methylsulfate Injection, USP is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery supplied by Fagron Sterile Services in a single-use syringe and is produced by Fagron Sterile Services into 5mL or 3mL fill presentation of 1 mg/mL of Neostigmine Methylsulfate. The impacted product Neostigmine Methylsulfate 1mg/mL can be identified by the following:

Lot Number Item Description NDC # Beyond-Use Date

C274-000004690

Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL (API) 71266-2003-02 9/21/2018

C274-000004678

Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, 5mL syringe (API)

71266-2003-01 9/20/2018

The impacted lots were distributed nationwide directly to hospitals and surgical clinics. Fagron Sterile Services has notified its direct customers by telephone and is arranging for return and replacement of all recalled products. Hospitals or surgical clinics that have received impacted product should immediately examine stock and discontinue dispensing. Promptly contact Stericycle to arrange product return at 1-888-918-8756, from Monday to Friday, 8:00am to 5:00pm EDT for instructions on how to return impacted product. Healthcare professionals which have the Neostigmine Methylsulfate products which are being recalled should stop use and return to Fagron Sterile Services.

Consumers with questions regarding this recall can contact Fagron Sterile Services by phone at 1-877-405-8066 M-F 8:00am – 5:00pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Source: U.S. Food and Drug Administration (FDA)

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

[Posted 07/10/2018]

ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems.

Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug.

RECOMMENDATION: The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:

• disturbances in attention • disorientation, agitation, nervousness • memory impairment • serious disturbances in mental abilities called delirium.

FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.

Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include:

• confusion • pounding heart or very fast pulse


• dizziness • pale skin • feeling shaky • sweating • unusual hunger • trembling • headaches • weakness • irritability • unusual anxiety

Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin.

• Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia.

• Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose. • Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side

effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non-fluoroquinolone antibiotic if possible.

• Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient’s treatment course.

Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online: www.medwatch.gov

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Source: U.S. Food and Drug Administration (FDA)


STUDIES AND RECENT TOPICS

Ranibizumab Shows Improved Outcomes for Patients with Concurrent DME, Macular Nonperfusion June 19, 2018 According to the results of a recent post hoc analysis for the RIDE and RISE studies, participants who had diabetic macular edema (DME) and concurrent baseline macular nonperfusion (MNP) experienced improved outcomes when treated with ranibizumab. Source: mdmag.com New flu vaccine only a little better than traditional shot June 20, 2018 A newer kind of flu vaccine only worked a little bit better in seniors this past winter than traditional shots, the government reported Wednesday. Overall, flu vaccines barely worked at all in keeping people 65 and older out of the hospital, with roughly 24 percent effectiveness. Source: apnews.com FDA slaps new bladder cancer limits on Merck's Keytruda, Roche's Tecentriq June 22, 2018 Last month, the FDA warned that immuno-oncology stars from Merck and Roche might actually be hurting some previously untreated bladder cancer patients’ survival chances. And now, it’s followed up by narrowing the drugs’ labels. The agency has restricted use of Merck’s Keytruda and Roche’s Tecentriq among patients with locally advanced or metastatic bladder cancer who aren’t eligible for cisplatin-containing chemo. Specifically, within that population, Keytruda is now OK’d only for patients whose tumors express levels of the biomarker PD-L1 that meet a combined positive score of 10 or higher. Tecentriq, meanwhile, can only be used for those whose PD-L1 immune cells cover 5% or more of their tumor area. Source: fiercepharma.com The Common Drug That May Make Opioid Overdose Five Times As Likely June 25, 2018 Opioid overdoses continue to increase, accounting for nearly two-thirds of all overdose deaths in the US, and a high percentage of those overdoses also include other drugs. A new study shows that the combination of opioids with one common class of drugs in particular is especially risky in the first 90 days of concurrent use. Those drugs are benzodiazepines (often called "benzos"), the class that includes


alprazolam (Xanax), diazepam (Valium), and clonazepam (Klonopin), meds frequently prescribed to alleviate anxiety. Source: forbes.com FDA Repays Industry by Rushing Risky Drugs to Market June 26, 2018 Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Source: propublica.org Betamethasone prevents human rhinovirus- and cigarette smoke- induced loss of respiratory epithelial barrier function June 26, 2018 The respiratory epithelium represents a first line of protection against airborne particles, including pathogens and allergens, and plays an important role in the regulation of airway inflammation and host defense1. The nasal and the bronchial epithelium are naturally exposed to a variety of different potentially damaging factors, which may injure the integrity of the mucosa by different mechanisms. Infections with respiratory viruses, exposure to cigarette smoke and/or exhaust fume as well as to protease-containing bioparticles and endogenous inflammatory factors are among the commonly encountered factors offending the respiratory tract. Source: nature.com Brain-protein structure could point way to safer prescription drugs June 27, 2018 The musician Tom Petty last year joined a long line of high-profile stars to hit the headlines for dying from an accidental overdose of prescription painkillers and tranquillizers. The risks of opioid painkillers dominate the news. But the other half of the deadly mixture in such overdose cases deserves attention, too. It’s typically a medicine from a class of drugs called benzodiazepines or — more colloquially — benzos. Source: nature.com US hospitals grapple with prolonged injected opioid shortage June 27, 2018 There is another opioid crisis happening in the U.S., and it has nothing to do with the overdose epidemic: Hospitals are frequently running out of widely used injected painkillers. Manufacturing shortages are forcing many doctors and pharmacists to sometimes ration injected opioids, reserving


them for the patients suffering most. Other patients get slower-acting or less effective pain pills, alternatives with more side effects or even sedation. Source: apnews.com Intravenous Eptinezumab Effectively Reduces Monthly Migraine Days June 28, 2018 A single intravenous 100 mg and 300 mg dose of eptinezumab is effective in reducing monthly migraine days (MMD) in patients with chronic migraine, according to a study presented by Paul Winner, DO, of the Palm Beach Headache Center/Premiere Research Institute at the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1, 2018 in San Francisco, California. Source neurologyadvisor.com Chronic pain patients, overlooked in opioid crisis, getting new attention from top at FDA July 2, 2018 Chronic pain patients and the groups that represent them say the escalating government response to opioid addiction ignores their need for the painkillers and doctors who will prescribe them, leaving some out of work, bedridden and even suicidal. Source: usatoday.com Fentanyl Is Causing Almost Half of All Overdose Deaths, Research Shows July 2, 2018 In a May 2018 research letter, the American Medical Association noted that of 2016’s more than 42,000 overdose deaths, nearly 46% involved fentanyl. Now, a study of a major metropolitan area is following suit, showing that national data of the opiate crisis is supported by smaller samples within a state. Source: fortune.com Metformin Could Accelerate Idiothatic Pulmonary Fibrosis Care July 5, 2018 New research has found that cell metabolism-targeting therapy metformin—commonly prescribed to patients with diabetes—can reverse the effects of lung fibrosis. At the conclusion of about 2 years of pre-clinical research, University of Alabama at Birmingham (UAB) Department of Medicine researchers Jaroslaw Zmijewski, PhD, and Victor Thannickal, MD have presented evidence from lung tissue-based analysis which showed the progressive disease can be resolved with acceleration by the non-insulin-dependent diabetes drug. Source: mdmag.com


Drugmakers try evasion, tougher negotiations to fight new U.S. insurer tactic July 5, 2018 In the escalating battle over U.S. prescription drug prices, major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs. Source: forbes.com FDA: New Warnings for Fluoroquinolones July 10, 2018 Manufacturers of fluoroquinolone antibiotics must update their labeling to warn about mental health issues and potential low blood sugar adverse reactions, the FDA said Tuesday. The labeling changes come after what the agency described as a "comprehensive review of the FDA's adverse event reports and case reports published in the medical literature," the agency said in a Drug Safety Communication. Source: medpagetoday.com


RECALLS

Product Type

Product Description

Classification Code Info Reason for Recall Recalling

Firm

Drugs

Neostigmine Methylsulfate

Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL

prefilled syringe, 5 syringes per

package, Rx only, Fagron Sterile Services, ICB Laboratories,

8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-

02.

Class I

Lot #: C274-000004690, BUD: 09/21/

18.

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1

mg per mL, 5 mg per 5 mL may be incorrectly labeled as

Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

Fagron Compoun

ding Services LLC dba

Drugs

Neostigmine Methylsulfate

Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL

prefilled syringe, 5 syringes per

package, Rx only, Fagron Sterile Services, ICB Laboratories,

8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-

01.

Class I

Lot #: C274-000004678, BUD: 09/20/

18

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1

mg per mL, 5 mg per 5 mL may be incorrectly labeled as

Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

Fagron Compoun

ding Services LLC dba

Drugs

Atorvastatin Calcium Tablets,

80 mg*, 90-count bottles, Rx Only,

Mfd. By: Dr. Reddy's

Laboratories Limited,

Class II Lot #:

T800064, Exp 12/2019

Presence of Foreign Substance: A product complaint was

received for a defective tablet with an embedded foreign object observed in a bottle.

Dr. Reddy's

Laboratories, Inc.


Product Type

Product Description


Firm Srikakulam - 532 409 INDIA, NDC

55111-124-90 UPC 355111124900

Drugs

0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira,

Inc. Lake Forest, IL 60045, NDC 0409-

7983-02

Class II

Lot #: 85-018-JT, 85-031-JT, Exp. 01/01/2020

Lack of assurance of sterility: Bags have potential to leak.

ICU Medical

Inc.

Drugs

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira,

Inc. Lake Forest, IL 60045, NDC 0409-

7984-23

Class II

Lot #: 85-021-JT, Exp 01/012020; 86-001-JT,

Exp 02/01/2020


ICU Medical

Inc.

Drugs

5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

Class II Lot #: 86-033-JT, Exp 08/01/2019


ICU Medical Inc.

Drugs

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Class II

Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Advanced Pharma Inc.


Product Type

Product Description


Firm

Drugs

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

Class II

Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19

Superpotent Drug: High out of specification assay value results for potency.

Ingenus Pharmaceuticals Llc

Drugs

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

Class II

Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19

Superpotent Drug: High out of specification assay value results for potency.

Ingenus Pharmaceuticals Llc


Product Type

Product Description


Firm

Drugs

Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 20180323@44, Exp 06/21/2018

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

SCA Pharmaceuticals, LLC

Drugs

Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018



Drugs

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 20180327@27, 20180327@40, 20180328@9, Exp 06/28/2018



Drugs

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals,

Class II

Lot # 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 12180016




Product Type

Product Description


Firm LLC, Windsor, CT 84, 1218001

721, 1218001763, 1218001764, Exp 07/26/2018-08/27/2018

Drugs

Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 1218000928, 1218000944, 1218000945, 1218001075, 1218001076, 1218001188, Exp 06/19/2018-07/03/2018



Drugs


Class II

Lot # 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, Exp 06/18/2018-07/11/2018



Drugs


Class II

Lot # 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 12180010




Product Type

Product Description


Firm 78, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210, Exp 06/19/2018-07/03/2018

Drugs

Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 20180323@24, Exp 06/21/2018



Drugs


Class II Lot # 20180323@24



Drugs


Class II

Lot # 20180323@29, Exp 06/21/2018



Drugs Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200

Class II Lot # 20180329@2, Exp 06/27/2018

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential

SCA Pharmaceuticals,


Product Type

Product Description


Firm mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

for leakage. LLC

Drugs

Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

Class II

Lot # 20180328@25, Exp 06/26/2018



Drugs

eb5 Skincare that Works. Age Spot Treatment. Skin

Lightening Cream with 2%

Hydroquinone. 177.4 ml / 6 fl oz carton containing

a tube. Manufactured

For: EB5 Corporation Portland, OR

97210 Carton Bar Code: 7 41099

00009 9

Class II Batch B4276A EXP 03/20

19

Failed Stability Specifications: Out-of-specification for

viscosity, pH and specific gravity

Eb5 Corporati

on

Drugs

Monsel's Solution (Ferric

Subsulfate), 20%, packaged as 12

single application vials and 12

applicators, 8 mL per box,

Manufactured For: MedGyn

Products, Inc., 100 W. Industrial Rd.,

Class II Lot #s: all lots within expi

ry

CGMP Deviations: The manufacturer of this product

recalled because they were not manufactured under current

good manufacturing practices.

Medgyn Products,

Inc.


Product Type

Product Description


Firm Addison, IL 60101

USA; Manufactured By:

BioDiagnostics Intl, 555 West Lambert Road

Unit-C, Brea, CA 92821, NDC

42721-112-08.

Drugs

Acetylcysteine for Injection 6 g/30

mL (200 mg/mL). Rx Only.

Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-

30.

Class II

Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/

2019

CGMP Deviations Akorn, Inc.

Drugs

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx

Only, Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873,

Manufactured for: Lupin

Pharmaceuticals, Inc. Baltimore,

MD 21202, UPC 343386-450-114, NDC 43386-450-

11

Class II

Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2

019

Subpotent Drug and Failed Content Uniformity.

LUPIN SOMERSE

T


Product Type

Product Description


Firm

Drugs

Admelog Solostar (insulin lispro injection), 100

units/ mL (U-100) injection,

packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician

Sample - Not For Sale, Sanofi-

Aventis U.S. LLC, Bridgewater, NJ

08807, NDC 0024-5925-00

Class II Lot #: 7F021B, Exp 6/30/

20

Temperature Abuse: Product samples of Admelog may not have been shipped at proper

temperature.

Sanofi-Aventis U.S. LLC

Drugs

Buffered Lidocaine 1% with

Sodium Bicarbonate

Injection for Local Anesthetic Use

(Concentration=10 mg/mL) 0.25 mL Total Volume, Rx

only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR

72205 877-550-5059

Class II

Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018

Subpotent Drug: Stability data does not support the current expiration dating of 55 days

after compounding.

SCA Pharmaceuticals

Drugs

Fluocinolone Acetonide Topical

Solution, USP, 0.01%, 60 mL

bottle, Rx Only, Manufactured by:

Actavis Laboratories UT,

Class II

Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 123112

Failed Impurities and Degradation Specifications and

Subpotent Drug: out-of-specification (OOS) test results

for below assay and above specification for degradants.

Teva Pharmaceuticals

USA


Product Type

Product Description


Firm Inc., Salt Lake City,

UT 84108 USA; Distributed by:

Actavis Pharmac, Inc., Parsippany, NJ 07054 USA,

NDC 0591-2990-60.

7, EXP 01/20

Drugs

Potassium Chloride For

Injection Concentrate

syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-

Fare Drug Pharmaceutical

Compounding 300 West Pine St., Blacksburg, SC

29702 800-622-0007

Class II Lot: 20180522@1 Exp.: 08/20/18

CGMP Deviations: Syringes were filled with 19mL of

potassium chloride when the labels displayed a fill of 20mL.

Medi-Fare Drug

and Home Health Center

Drugs

Atorvastatin Calcium Tablets,

10 mg*, 90-count bottle, Rx Only,

Mfd. By: Dr. Reddy's

Laboratories Limited,

Srikakulam - 532 409 INDIA, NDC 55111-121-90

Class III

Lot #: T600327,

Exp 07/18; T700213, T700215, Exp 04/19

Failed Impurities/Degradation Specifications

Dr. Reddy's

Laboratories, Inc.

Drugs

0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For:

Class II

Lot # 5/14/18 0749 525-66102, BUD 6/13/2018; 5/22/18 0837 495-66102, BUD 6/21/

Lack of Assurance of Sterility: Potential leakage of bags.

Avella of Deer Valley, Inc.


Product Type

Product Description


Firm Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02

2018

Drugs

ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10

Class II

Lot # 4/27/18 2002 60410P, 4/27/18 2030 60410P, BUD 6/26/2018



Drugs

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61

Class II

Lot # 3/5/18 8055 80561S, 3/5/18 0514 80561S, 3/5/18 5259 80561S, 3/5/18 6131 80561S, 3/5/18 5641 80561S, BUD 7/3/2018; 5/10/18 1312 80561S, 5/10/18 1322 80561S, BUD 9/7/2018;




Product Type

Product Description


Firm

Drugs

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.

Class II

Lot # 5/4/18 0300 58-85525P, BUD 6/18/2018; 5/10/18 1435 262-85525P, 5/10/18 1127 558-85525P, BUD 6/24/2018; 5/11/18 1327 457-85525P, BUD 6/25/2018; 5/14/18 0302 295-85525P, BUD 6/28/2018; 5/17/18 0500 558-85525P, BUD 7/1/2018; 5/24/18 1005 57-85525P, 5/24/18 1328 295-85525P, BUD 7/7/2018; 5/25/18 0302 295-85525P, BUD 7/9/2018; 5/30/18 0936 262-85525P, BUD 7/14/2018; 5/31/180805 558-85525P, BUD 7/17/2018.



Drugs

EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL

Class II

Lot # 4/30/18 0512 2-82325P, BUD 6/14/2018; 5/22/18 1238




Product Type

Product Description


Firm single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.

82325P, BUD 7/6/2018.

Drugs

fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70

Class II

Lot # 5/3/18 0317 142-21070S, BUD 8/1/2018; 5/10/18 0512 144-21070S, BUD 8/8/2018; 6/1/18 0305 142-21070S , BUD 8/30/2018; 6/4/18 0505 252-21070S, BUD 9/2/2018.



Drugs

HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Phoenix AZ 85085. NDC 42852-729-25

Class II

Lot # 138-20181505@92, BUD 8/23/2018; 138-20181605@78, BUD 8/24/2018




Product Type

Product Description


Firm

Drugs

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

Class II

Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.



Drugs

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65

Class II

Lot # 5/16/18 1207 22265S, BUD 8/14/2018.



Drugs

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX

Class II

Lot # 5/1/18 0501 548-90510P, BUD 7/30/2018.




Product Type

Product Description


Firm 77054. NDC: 42852-905-10

Drugs

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

Class II

Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.



Drugs

MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10

Class II

Lot #: 5/15/18 6413 24110P, BUD; 9/12/2018; 5/16/18 0744 24110P, BUD 9/13/2018.



Drugs

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume:

Class II

Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 8152




Product Type

Product Description


Firm 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

5P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.

Drugs

PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25

Class II

Lot # 5/23/18 3812 89325P, BUD 8/6/2018.



Drugs

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25

Class II

Lot # 138-20181005@92, 138-20181005@91, 138-20181005@90, BUD 7/9/2018; 138-20181405@78, BUD 7/13/2018; 138-20181605@61, BUD 7/15/2018




Product Type

Product Description


Firm

Drugs

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87

Class II

Lot 5/14/18 0722 47-00287Y EXP 06/28/2018



Drugs

ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61

Class II

Lot #: 05/10/18 2011 89161S, BUD 9/7/2018



Drugs

fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg,

Class II

Lot #: 5/14/18 0913 320-25087Y, BUD 6/28/2018.




Product Type

Product Description


Firm 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87

Drugs

fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72

Class II

Lot #: 5/24/18 0502 149-21072S, BUD 8/22/2018.



Drugs

fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For:

Class II

Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018.




Product Type

Product Description


Firm Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86

Drugs

HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25

Class II

Lot #: 138-20181105@65,138-20181105@64, 138-20181105@63, BUD 8/19/2018.



Drugs

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC

Class II

Lot #: 5/1/18 0511 515-74725P, BUD 7/30/2018.




Product Type

Product Description


Firm 42852-747-25

Drugs

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63

Class II

Lot #: 3/15/18 0954 22263M, BUD 6/13/2018.



Drugs

HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10

Class II

Lot #: 4/26/18 0520 22110P, BUD 8/9/2018; 5/14/18 1350 22110P, BUD 8/27/2018.



Drugs

MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume:

Class II

Lot #: 5/15/18 0510 169-90610P, BUD 8/13/2018.




Product Type

Product Description


Firm 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10

Drugs

MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10

Class II

Lot #: 5/2/18 0318 284-90710P, BUD 7/31/2018; 5/9/18 0502 423-90710P, BUD 8/7/2018; 5/18/18 0500 284-90710P, BUD 8/16/2018.



Drugs

MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25

Class II

Lot #:2/26/18 0301 24125P, BUD 6/26/2018.




Product Type

Product Description


Firm

Drugs

MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63

Class II

Lot #:2/26/18 2233 24363M, BUD 6/26/2018.



Drugs

Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63

Class II

Lot #:5/11/18 1050 28-40163M, BUD 7/25/2018.



Drugs

Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables

Class II

Lot #:5/21/18 0506 240-40810P, BUD 8/4/2018; 5/22/18 0501 86-40810P, BUD 8/5/2018; 5/25/18 0900 410-




Product Type

Product Description


Firm Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10

40810P, BUD 8/8/2018; 6/6/18 0836 86-40810P, BUD 8/20/2018.

Drugs

Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76

Class II

Lot #:5/14/18 2011 40176S, BUD 9/11/2018.



Drugs

NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25

Class II

Lot #:4/26/18 0515 83425P, BUD 6/25/2018; 4/24/18 1332 83425P, BUD 6/23/2018.



Drugs

NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of

Class II

Lot #: 5/7/18 0301 2-80761S, BUD 6/21/2018; 5/9/18 0510 2-80761S, BUD 6/23/20




Product Type

Product Description


Firm Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61

18; 5/21/18 1807 80761S, BUD 7/15/2018.

Drugs

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25

Class II

Lot #: 4/30/18 2471 80725P, BUD 6/29/2018; 5/1/18 1240 80725P, BUD 6/30/2018; 5/8/18 1111 80725P BUD 7/7/2018.



Drugs

PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25

Class II

Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. .



Drugs

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL.

Class II

Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/20




Product Type

Product Description


Firm Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

18; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .

Drugs

Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Class II

Lot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018

Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

La Vita Compounding Pharmacy, LLC

Drugs

Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Class II

Lot #: 140089@1, Exp 08/06/2018; 141968@6, Exp 09/03/2018; 143381@2, Exp 09/24/2018; 145265@13, Exp 10/22/2018; 146479@6, Exp 11/12/2018




Product Type

Product Description


Firm

Drugs

Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Class II

Lot #: 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018



Drugs

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02

Class II Lot #: JKT0042A, Exp 1/2021

Presence of foreign substance: One lot of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.

Sun Pharmaceutical Industries, Inc.

Drugs

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume

Class II

Lot #: 5/10/18 1451 89561S, BUD 9/7/2018 .




Product Type

Product Description


Firm 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61

Drugs

alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.

Class II

Lot Codes: a) 7363B, 7363I, 8002C, 8002I, 8054J, 8055B, 8174A; and b) 7353

Incorrect Product Formulation: wrong sunscreen product in the package.

The Hain Celestial Group, Inc.

Drugs

PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX

Class II

Lot #: 4/30/18 0732 558-85625P, BUD 6/29/2018 .




Product Type

Product Description


Firm 77054 NDC 15082-856-25

Drugs

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03

Class II All lots within expiry.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Prinston Pharmaceutical Inc

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.

Class II

Lot # 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, 1277709M


Teva Pharmaceuticals USA


Product Type

Product Description


Firm

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.

Class II

Lot Numbers: 1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, 1253254M



Drugs

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

Class II

Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19).


MAJOR PHARMACEUTICALS


Product Type

Product Description


Firm

Drugs

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only., Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

Class II

Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087. Lot# T-01269 (Expiry: 7/18). Lot# T-01524 (Expiry: 2/19). Lot# T-01646 (Expiry: 5/19). Lot# T-01668 (Expiry: 5/19). Lot# T-01788 (Expiry: 5/19).


MAJOR PHARMACEUTICALS

Drugs

Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09




Drugs

Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by:





Product Type

Product Description


Firm Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09

Drugs

Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09




Drugs

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China





Product Type

Product Description


Firm Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09

Drugs

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09




Drugs

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury,

Class II All lots within expiry




Product Type

Product Description


Firm NJ 08512 USA NDC 43547-313-09

Drugs

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09




Drugs

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-





Product Type

Product Description


Firm 09

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.

Class II

Lot Numbers: 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, 1288798M



Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19

Class II

Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M



Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP,

Class II

Lot Numbers: 1191188M, 1191189M, 1191190M, 1199220




Product Type

Product Description


Firm 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.

M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M

Drugs

Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Class II

Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A



Drugs

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma,

Class II

Lot Numbers: NDC 0591-2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-2168-10 1177114A, 1219360M,




Product Type

Product Description


Firm Inc. Parsippany, NJ 07054

1250706A

Drugs

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Class II

NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A



Drugs

Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.

Class II

NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A



Drugs

Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr.

Class III Lot #: T600328, Exp 07/18; T700214, T700216, Ex


Dr. Reddy's Laboratories, Inc.


Product Type

Product Description


Firm Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90

p 04/19

Drugs

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Class III

Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18


Dr. Reddy's Laboratories, Inc.

Drugs

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Quale 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Class III

lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

Labeling: Incorrect or Missing Lot and/or Exp Date.

Quale, LLC

Drugs

Enalapril Maleate Tablets USP, 5 mg,

100 Tablets (10X10) blister

cards, 12 cartons in a shipper, Rx, Packaged and

Class III

Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053

Failed Impurities/Degradation Specification; out-of-

specification results for the Enalapril DKT degradant

AMERICAN

HEALTH PACKAGI

NG


Product Type

Product Description


Firm Distributed by:

American Health Packaging,

Columbus, OH --- NDC 68084-390-

01 Carton [68084-390-11 - Unit

Dose]

units).

Drugs

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Class III

lot# D001 EXP: 01/02/2018 CPD: 01/02/2019

Labeling: Incorrect or Missing Lot and/or Exp Date.

Qualgen, LLC

Drugs

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

Class III

a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, Exp 3/20; S700228, Exp 4/20; S700304, Exp 5/20; S700510, Exp 7/20; S700780, Exp 10/20; S701063, S701112, Exp 12/20; S800170, Exp 2/21; S800349,

Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

LUPIN SOMERSET


Product Type

Product Description


Firm Exp 3/21; S800366, Exp 4/21; S800453, Exp 5/21; b) M16560A, M16561A, M16562A, Exp 9/19; M16607A, Exp 11/19; S700202, Exp 4/20; S700415, Exp 6/20; S700511, Exp 7/20; S700752, Exp 9/20; S700902, Exp 10/20; S701119, Exp 12/20; S800097, Exp 2/21; S800296, S800306, Exp 3/21

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm


CURRENT DRUG SHORTAGES

Sincalide Injection June 20, 2018 Reason for the Shortage

• Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption. • There are no approved alternatives to Kinevac for the labeled indications.

Estimated Resupply Dates

• Bracco has Kinevac on intermittent backorder and on allocation when available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277 Abciximab Injection June 20, 2018 Reason for the Shortage

• Janssen has Reopro on shortage due to a production interruption at their third party manufacturing site. The contract manufacturer cannot guarantee supply continuity in 2018 and beyond.

• There are no other suppliers of abciximab. Estimated Resupply Dates

• Janssen has Reopro on long-term back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=413 0.9% Sodium Chloride 10 Ml, 20 Ml, and 50 Ml Preservative Free Vials and Syringes June 20, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing

delays. Estimated Resupply Dates

• Fresenius Kabi has 0.9% sodium chloride preservative free 10 mL and 20 mL vials on back order and the company estimates a release date of mid-July 2018 for the 10 mL vials and late-June 2018 for the 20 mL vials.

• Pfizer has 0.9% sodium chloride preservative free 10 mL LifeShield syringes on back order and the company estimates a release date of July 2018. The 10 mL and 20 mL vials are on back order and the company estimates a release date of July 2018. The 50 mL vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332


Sodium Polystyrene Sulfonate Oral Or Rectal Suspension June 21, 2018 Reason for the Shortage

• CMP Pharma has SPS Suspension available. • Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate

suspension. They cannot estimate when these products will be manufactured again. • West-Ward did not provide a reason for the shortage.


• West-Ward has sodium polystyrene sulfonate suspension in 60 ml and 120 mL bottles on back order and the company cannot estimate a release date. The 500 mL bottles are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=430 Nitroglycerin Injection June 21, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • The premixed bags are not affected by this shortage.


• American Regent has nitroglycerin 50 mg/mL 10 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=289 Morrhuate Sodium Injection June 21, 2018 Reason for the Shortage

• American Regent has morrhuate sodium injection on shortage due to manufacturing delays. Estimated Resupply Dates

• American Regent has morrhuate sodium 50 mg/mL 30 mL vials on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=37 Dobutamine Injection June 21, 2018 Reason for the Shortage

• Baxter has dobutamine on shortage due to manufacturing delays. • Pfizer has dobutamine on shortage due to manufacturing delays.


• Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated release date of 2019 for the 20 mL vials and 2018 for the 40 mL vials. The 12.5 mg/mL 20 mL regular vials in 10 count are on back order and the company estimates a release date of July 2018.


• Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a release date of August 2018. The dobutamine 2 mg/mL 250 mL bags are on back order and the company estimates a release date of July 2018. The dobutamine 4 mg/mL 250 mL bags are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Dipyridamole Injection June 21, 2018 Reason for the Shortage

• West-Ward did not provide a reason for the shortage. Estimated Resupply Dates

• West-Ward has dipyridamole 5 mg/mL 10 mL vials on a weekly allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=345 Ceftazidime Injection June 21, 2018 Reason for the Shortage

• Pfizer has Tazicef available. • Sagent had ceftazidime injection on shortage due to manufacturing delays. • Sandoz discontinued ceftazidime 1 gram and 2 gram vials in 2015. Sandoz discontinued the 6

gram vials in early 2016. • BBraun had ceftazidime on allocation due to increased demand. • Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50

mL premixes in February 2018. • WG Critical Care has ceftazidime available.


• Pfizer has Tazicef 1 gram ADD-Vantage vials on back order and the company estimates a release date of August 2018. The 2 gram ADD-Vantage vials are available in limited supply.

• BBraun has ceftazidime 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Teligent has Fortaz 500 mg vials on long-term back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63 Cefoxitin Sodium Injection June 21, 2018 Reason for the Shortage

• Fresenius Kabi and West-Ward did not provide a reason for the shortage. • Sagent had cefoxitin on shortage due to manufacturing delays. • BBraun has cefoxitin on allocation due to increased demand. • WG Critical Care did not provide a reason for the back order. • Apotex did not provide a reason for the shortage.



• Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company cannot estimate when product will be available again.

• BBraun has cefoxitin 1 gram and 2 gram vials on allocation. • Sagent has cefoxitin 1 gram vials on allocation. • West-Ward has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company

estimates a release date of July 2018 for the 1 gram vials and cannot estimate a release date for the 2 gram and 10 gram vials.

• WG Critical Care has cefoxitin 1 gram vials on back order and the company estimates a release date of early-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Bumetanide Injection June 21, 2018 Reason for the Shortage

• Pfizer has bumetanide injection on shortage due to manufacturing delays. • West-Ward did not provide a reason for the shortage.


• Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of 2019.

• West-Ward has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on a weekly allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Selenium Injection (As Selenious Acid) June 22, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. Estimated Resupply Dates

• American Regent has selenium 40 mcg/mL 10 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=308 Belladonna and Opium Suppositories June 22, 2018 Reason for the Shortage

• Perrigo has belladonna and opium suppositories on shortage because they are waiting to get more raw ingredient.


• Perrigo has belladona and opium 16.3 mg/30 mg and 16.3 mg/60 mg suppositories on back order and the company estimates a release date of late-3rd quarter 2018.



Thiothixene Capsules June 25, 2018 Reason for the Shortage

• Mylan did not provide a reason for the shortage. • Mylan is the sole supplier of thiothixene.


• Mylan has thiothixene 1 mg capsules in 100 count bottles on back order and the company cannot estimate a release date.

• Mylan Institutional has thiothixene 2 mg, 5 mg, and 10 mg capsules in 100 count unit-dose blister packs on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=418 Remifentanil Injection June 25, 2018 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Fresenius Kabi launched generic remifentanil in January 2018.


• Mylan Institutional has Ultiva 2 mg vials on back order and the company estimates a release date of mid-August 2018.

• Fresenius Kabi has remifentanil 1 mg, 2 mg, and 5 mg vials on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=371 Multiple Vitamins For Infusion June 25, 2018 Reason for the Shortage

• Pfizer states the shortage is due to manufacturing delays. • Baxter has all presentations fully available at this time.


• Pfizer has M.V.I. adult 50 mL Dual vials on back order and the company estimates a release date of July 2018. The 5 mL pediatric vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69 Isocarboxazid Tablets June 25, 2018 Reason for the Shortage

• Validus has Marplan tablets on shortage due to manufacturing delays. Estimated Resupply Dates

• Validus has Marplan on back order and the company cannot estimate a release date.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411 Aminophylline Injection June 25, 2018 Reason for the Shortage

• Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has aminophylline 25 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Aminocaproic Acid Injection June 25, 2018 Reason for the Shortage

• Pfizer has aminocaproic acid on shortage due to manufacturing delays. [1] Estimated Resupply Dates

• Pfizer has aminocaproic acid 250 mg/mL 20 mL vials on back order and the company estimates a release date of July 2018.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=346 0.9% Sodium Chloride Large Volume Bags June 25, 2018 Reason for the Shortage

• Baxter discontinued 0.9% sodium chloride 250 mL and 500 mL AVIVA bags. The Viaflex bags and Viaflo bags are on allocation.[1]

• BBraun did not provide a reason for the shortage.[2] • ICU Medical cited increased demand as the reason for the shortage.[3] • Fresenius Kabi is no longer importing product.[8] • Baxter has received FDA approval for 0.9% sodium chloride in Viaflo containers manufactured in

an FDA-approved facility in Spain. Additional information about this product is available at: http://www.baxter.com/information/saline_supply.html.


• Baxter has all 0.9% sodium chloride presentations on allocation.[1] • BBraun has 0.9% sodium chloride 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on

allocation to current customers.[2] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=76 Sodium Bicarbonate Injection June 26, 2018 Reason for the Shortage

• Amphastar has sodium bicarbonate injection available.[1]


• Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.[2] • Fresenius Kabi has reintroduced sodium bicarbonate injection in response to the shortage.[3]


• Pfizer has sodium bicarbonate 4.2% 10 mL LifeSheild syringes on back order and the company estimates a release date of August 2018. The 8.4% 10 mL syringes are on back order and the company estimates a release date of August 2018.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Etomidate Injection June 26, 2018 Reason for the Shortage

• American Regent did not provide a reason for the current shortage. • AuroMedics has etomidate available. • Mylan did not provide a reason for the current shortage. • Par Sterile Products discontinued etomidate in early 2015. • Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate

ampules in October 2016. • Sagent is no longer marketing etomidate. • West-Ward has etomidate available. • Zydus had etomidate on shortage due to an increase in demand.


• American Regent has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot estimate a release date.

• Mylan Institutional has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of late-October to early-November 2018.

• Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Calcium Gluconate Injection June 26, 2018 Reason for the Shortage

• American Regent has calcium gluconate on shortage due to manufacturing delays. • Fresenius Kabi has calcium gluconate available with alternating short-dating due to

manufacturing process of the vials. Estimated Resupply Dates

• American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has calcium gluconate 100 mg/mL 10 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of mid- to late-July 2018. Check wholesalers for inventory.



Calcium Chloride Injection June 26, 2018 Reason for the Shortage

• American Regent has calcium chloride injection available. • Amphastar has calcium chloride injection available. • Pfizer has calcium chloride on shortage due to manufacturing delays. • Mylan Institutional has withdrawn calcium chloride syringes from the market. The company

recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.


• Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes and 100 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Morphine Pca Vials June 27, 2018 Reason for the Shortage

• ICU Medical has morphine PCA vials on allocation due to increased demand. [1] • Amphastar's morphine PCA vials are not affected by the shortage.[2]


• ICU Medical has morphine PCA vials on allocation. [1] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=436 Midodrine Tablets June 27, 2018 Reason for the Shortage

• Upsher-Smith did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage.


• Upsher-Smith has midodrine 2.5 mg, 5 mg, and 10 mg tablets in 100-count bottles on intermittent back order with regular releases. Product is being allocated upon release.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=439 Furosemide Injection June 27, 2018 Reason for the Shortage

• American Regent is not actively marketing furosemide injection. • Amneal did not provide a reason for the shortage. • Baxter (formerly Claris) has furosemide injection available. • Fresenius Kabi did not provide a reason for the shortage. • Heritage has furosemide injection available.


• Pfizer has furosemide injection on shortage due to manufacturing delays and increased demand. Estimated Resupply Dates

• Amneal has furosemide 10 mg/mL 2 mL vials available with a short expiration date (November 2018).

• Fresenius Kabi has furosemide 10 mg/mL 10 mL vials on back order and the company estimates a release date of late-July 2018.

• Pfizer has furosemide 10 mg/mL 4 mL syringes on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Nitrofurantoin Oral Suspension June 28, 2018 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Casper Pharma and Lupin Pharmaceuticals were not available to provide information. • Lupin is no longer manufacturing this product. • Nostrum is no longer manufacturing this product. • Teva did not provide a reason for the shortage.


• Amneal has nitrofurantoin oral suspension on back order and the company cannot estimate a release date.

• Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a release date.

• Lupin and Nostrum have discontinued the production of nitrofurantoin oral suspension. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433 Hepatitis A Virus Vaccine Inactivated June 28, 2018 Reason for the Shortage

• Merck did not provide a reason for the Vaqta shortage. • GlaxoSmithKline did not provide a reason for the shortage. • GlaxoSmithKline discontinued the Havrix adult vials in November 2017.


• Merck has Vaqta adult formulation 50 U/1 mL vials in 1 count on back order and the company does not expect it will be available in 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=280 Potassium Phosphate Injection June 29, 2018 Reason for the Shortage

• American Regent has not had potassium phosphate injection available since 2012. It is unclear if and when product will return to market.


• Fresenius Kabi had potassium phosphate injection on shortage due to increased demand. • Pfizer had potassium phosphate injection on shortage due to manufacturing delays.


• All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305 Moxifloxacin Injection June 29, 2018 Reason for the Shortage

• Bayer discontinued Avelox IV in December 2017. • Fresenius Kabi had moxifloxacin injection on shortage due to increased demand. • Mylan Institutional did not provide a reason for the shortage.


• Mylan Institutional has moxifloxacin 400 mg/250 mL premixed bags on back order and the company estimates a release date of early-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=357 Metoprolol Injection June 29, 2018 Reason for the Shortage

• Alvogen has metoprolol injection available.[1] • American Regent has had metoprolol injection on long-term back order for several years.[2] • Athenex has metoprolol injection available.[3] • Claris did not provide a reason for the shortage.[4] • Fresenius Kabi has metoprolol injection on shortage due to increased demand.[5] • Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol

injection in March 2018.[6] • Pfizer has metoprolol injection on shortage due to manufacturing delays.[7] • West-Ward has metoprolol injection available.[8]


• Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company cannot estimate a release date.[4]

• Pfizer has metoprolol 1 mg/mL 5 mL ampules and 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a release date of 2019. The 1 mg/mL 5 mL vials are available in limited supply.[7]

• West-Ward has metoprolol 1 mg/mL 5 mL vials on allocation. The 1 mg/mL 10 mL vials are on back order and the company estimates a release date of July 2018.[8]



Methylphenidate Extended-Release Oral Suspension and Chewable Tablets June 29, 2018 Reason for the Shortage

• Pfizer has Quillivant XR on shortage due to manufacturing delays. • Pfizer has QuillChew ER chewable tablets available.


• Pfizer has Quillivant XR 5 mg/mL extended-release oral suspension in 60 mL bottles and 120 mL bottles on back order and the company estimates a release date of August to September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=373 Methyldopate Injection June 29, 2018 Reason for the Shortage

• American Regent has methyldopate injection on shortage due to manufacturing delays. • There are no other suppliers of methyldopate injection.


• American Regent has methyldopate injection on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=130 Fentanyl Citrate Injection June 29, 2018 Reason for the Shortage

• Akorn has fentanyl injection on shortage due to increased demand. • West-Ward has fentanyl injection on shortage due to supply and demand issues. • Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were

discontinued in September 2017. Estimated Resupply Dates

• Akorn has Sublimaze 50 mcg/mL 2 mL ampules in 10 count and 25 count, and 5 mL ampules in 10 count and 25 count on allocation.

• Pfizer has fentanyl 50 mcg/mL 2 mL and 5 mL ampules on back order and the company estimates a release date of August 2018 for the 2 mL ampules and mid-August 2018 for the 5 mL ampules. The 2 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 2 mL, 5 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of August 2018 for the 2 mL vials, early-August 2018 for the 5 mL vials, mid-August 2018 for the 20 mL vials, and late-July 2018 for the 50 mL vials.

• West-Ward has fentanyl 50 mcg/mL 2 mL, 5 mL, and 50 mL vials on allocation. The 20 mL vials are on back order and the company estimates a release date of early-July 2018. The 2 mL, 5 mL, and 20 mL ampules are on back order and the company cannot estimate a release date.



Dopamine Hydrochloride Injection June 29, 2018 Reason for the Shortage

• American Regent has dopamine on shortage due to manufacturing delays. • Baxter had dopamine on shortage due to manufacturing delays. • Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and

400 mg/500 mL premixed bags were discontinued in August 2017. Estimated Resupply Dates

• American Regent has all dopamine presentations on back order and the company cannot estimate a release date.

• Pfizer has dopamine 40 mg/mL 10 mL vials on back order and the company estimates a release date of 2019. The 400 mg/250 mL bags are on back order and the company estimates a release date of August 2018. The 800 mg/250 mL premixed bags are on back order and the company estimates a release date of November 2018. The 800 mg/500 mL bags are on back order and the company estimates a release date of November 2018. The 40 mg/mL 5 mL vials are on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Cisplatin Injection June 29, 2018 Reason for the Shortage

• Athenex has cisplatin available.[1] • Fresenius Kabi has cisplatin available.[2] • Mylan Institutional discontinued cisplatin in January 2018.[3] • Teva had cisplatin on allocation due to increased demand.[4] • WG Critical Care has cisplatin available.[5]


• Fresenius Kabi has cisplatin 1 mg/mL 50 mL and 200 mL vials available with short-expiration dating of <9 months. The 100 mL vials are on back order and the company estimates a release date of late-July to early-August 2018.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=96 2% Lidocaine Hydrochloride Topical Jelly June 29, 2018 Reason for the Shortage

• Akorn has 2% lidocaine jelly on shortage due to increased demand. • Teva discontinued lidocaine jelly in early-2018. • Glydo and Uro-Jet prefilled syringes are not affected by this shortage.


• Akorn has 2% lidocaine jelly 5 mL and 30 mL tubes on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=400


Octreotide Injection July 2, 2018 Reason for the Shortage

• Fresenius Kabi has octreotide available. • Mylan Institutional has octreotide available. • Sagent has octreotide on shortage due to manufacturing delays. • Sun Pharma did not provide a reason for the shortage. • Teva has octreotide available. • Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018. • Hikma did not provide a reason for the shortage.


• Fresenius Kabi has octreotide 50 mcg/mL 1 mL vials on back order and the company cannot estimate a release date.

• Hikma has all presentations available but with short expiration dating. • Sagent has 500 mcg/mL 1 mL vials on allocation. • Sun Pharma has all octreotide presentations on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Multiple Vitamin Oral Liquid July 2, 2018 Reason for the Shortage

• Major has discontinued CertaVite with Antioxidants. • Pfizer has Centrum liquid available. • Rugby has Cerovite liquid on shortage due to the PharmaTech recall in August 2017. Several

products were recalled due to potential contamination with Burkholderia cepacia. Estimated Resupply Dates

• Rugby has Cerovite liquid unavailable. The company plans to re-launch Cerovite in mid-July 2018. The product will have a new NDC number (00536-1153-59).

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=392 Heparin Injection July 2, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage. • Sagent had heparin on shortage due to manufacturing delay. • Hikma did not provide a reason for the shortage.


• Fresenius Kabi has all presentations available. • Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a

release date of 2019. The 1,000 unit/mL 10 mL vials are on back order and the company


estimates a release date in August 2018. The 10,000 unit/mL 1 mL vials, and 1000 unit/mL 30 mL vials are on back order and the company cannot estimate a release date.

• Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company cannot estimate a release date. The 1,000 unit/mL 2 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Epinephrine Injection July 2, 2018 Reason for the Shortage

• Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.[1]

• Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2] • BPI has epinephrine 1 mg/mL 2 mL ampules available.[3] • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]


• Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1] • Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a

release date of July 2018.[2] • Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an

epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Cefazolin Injection July 2, 2018 Reason for the Shortage

• Apotex has discontinued all presentations except cefazolin 10 gram vials. The 10 gram vials are not currently being manufactured.

• Baxter did not provide a reason for the shortage. • BBraun did not provide a reason for the shortage. • Fresenius Kabi has most cefazolin products available. • Pfizer states the reason for the shortage is manufacturing delay. • Sagent states the reason for the shortage is manufacturing delays and increased demand. • Samson Medical Technologies has cefazolin injection available. • Sandoz has cefazolin injection available. • Hikma did not provide a reason for the shortage. • WG Critical Care did not provide a reason for the shortage.


• Baxter has cefazolin 2 gram/100 mL premixed bags on allocation. • BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Fresenius Kabi has cefazolin 500 mg and 1 gram vials on back order and the company estimates

a release date in late-August 2018. The 20 gram bulk vials are on back order and the company cannot estimate a release date.


• Pfizer has 1 gram and 10 gram vials on back order and the company cannot estimate a release date.

• Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on back order and the company estimates a release date in August 2018.

• Hikma has cefazolin 500 mg vials on back order and the company estimates a release date in July 2018. The 1 gram vials are on allocation.

• WG Critical Care has cefazolin 500 mg vials on back order and the company estimates a release date in mid- to late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 5% Dextrose Injection July 2, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • ICU Medical states the shortage is due to increased demand. • Pfizer states that the shortage is due to increased demand. • ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. Pfizer

continues to market the ADD-vantage product. Estimated Resupply Dates

• Baxter has 5% dextrose 250 mL, 500 mL, and 1,000 mL bags on allocation. • Pfizer has 5% dextrose 250 mL ADD-Vantage bags on back order with an estimated release date

of July 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=303 Vincristine Sulfate Injection July 3, 2018 Reason for the Shortage

• Pfizer has vincristine on shortage due to manufacturing delays. • Teva has Vincasar available.


• Pfizer has vincristine 1 mg/mL 2 mL vials on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=382 Sodium Acetate Injection July 3, 2018 Reason for the Shortage

• American Regent has had sodium acetate on long-term back order for several years. • Fresenius Kabi had sodium acetate on shortage due to increased demand. • Pfizer has sodium acetate on shortage due to manufacturing delays.



• Pfizer has sodium acetate 2 meq/mL 50 mL vials on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Methotrexate Injection July 3, 2018 Reason for the Shortage

• Accord did not provide a reason for the shortage.[1] • Fresenius Kabi has methotrexate injection available.[2] • Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued

the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3] • Pfizer has methotrexate injection available.[4] • Teva had methotrexate injection on shortage due to increased demand.[5] • West-Ward has methotrexate injection available.[6]


• Fresenius Kabi has methotrexate 1 gram vials of lyophilized powder for solution on back order and the company estimates a release date of mid-July 2018.

• Pfizer has methotrexate 25 mg/mL 2 mL vials on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Methadone Injection July 3, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Mylan Institutional has methadone injection available.


• Akorn has methadone injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=358 Lidocaine Injection July 3, 2018 Reason for the Shortage

• Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product.

• AuroMedics introduced lidocaine injection in February 2014. • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of

raw ingredients. • Pfizer has lidocaine presentations on shortage due to manufacturing delays.


• AuroMedics has 1% lidocaine 2 mL and 5 mL ampules and 2 mL, 5 mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available.


AuroMedics has 2% lidocaine 2 mL ampules and 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has 0.5% Xylocaine 50 mL and 50 mL MPF vials on back order and the company estimates a release date of August 2018. The 1% lidocaine 10 mL vials are on back order and the company estimates a release date of early-July 2018. The 1% Xylocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of early-July 2018 for the 20 mL vials and mid-August 2018 for the 50 mL vials. The 1% Xylocaine-MPF 2 mL, 5 mL, and 30 mL vials are on back order and the company estimates a release date of early July 2018. The 1% Xylocaine-MPF 10 mL vial sterile packs are on back order and the company estimates a release date of late-August 2018. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of early September 2018. The 2% Xylocaine 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of early-July 2018. The 2% Xylocaine-MPF 2 mL and 5 mL vials are on back order and the company estimates a release date of early-July 2018 for the 2 mL vials and mid-August 2018 for the 5 mL vials. The 2% lidocaine 5 mL preservative free vials are on back order and the company estimates a release date of early-July 2018. Check wholesalers for inventory.

• Pfizer has 0.5% lidocaine 50 mL tear top and flip top vials on back order and the company estimates a release date of August 2018. The 1% lidocaine 2 mL preservative-free ampules on back order and the company estimates a release date of July 2018. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of 2019. The 1% lidocaine 20 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of July 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of August 2018. The 2% lidocaine 2 mL preservative-free ampules are on back order and the company estimates a release date of September 2018. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of 2019. The 2% lidocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of August 2018. The 2% lidocaine 5 mL Lifeshield and 5 mL Ansyr syringes are on back order and the company estimates a release date in July 2018. The 4% lidocaine 5 mL ampules are on back order and the company estimates a release date of August 2018.

• Hikma has 1% lidocaine 5 mL preservative-free vials, 1% lidocaine 50 mL vials, and 2% lidocaine 50 mL vials on allocation. The 2% lidocaine 5 mL preservative free vials are on back order and the company estimates a release date of August to September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Ketamine Injection July 3, 2018 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Par has Ketalar on shortage due to increased demand. • Pfizer has ketamine on shortage due to manufacturing delays. • West-Ward did not provide a reason for the shortage.


• Mylan Institutional has ketamine 10 mg/mL 20 mL and 50 mg/mL 10 mL vials on back order and the company estimates a release date of early-July 2018 for the 10 mg/mL 20 mL vials and late-October to early-November 2018 for the 50 mg/mL 10 mL vials.


• Pfizer has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on back order and the company estimates a release date of 2019.

• West-Ward has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on allocation. • Par has Ketalar 10 mg/mL 20 mL vials, 50 mg/mL 10 mL vials, and 100 mg/mL 5 mL vials on

intermittent back order with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Iron Dextran Injection July 3, 2018 Reason for the Shortage

• Allergan has INFeD on shortage due to manufacturing delays. • American Regent discontinued Dexferrum injection in 2014.


• Allergan has INFeD 50 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=408 Etoposide Solution For Injection July 3, 2018 Reason for the Shortage

• Accord has etoposide 20 mg/mL 5 mL and 25 mL vials on allocation and 50 mL vials on back order due to increased demand.

• Fresenius Kabi has etoposide on back order due to increased demand. • Teva has Toposar on allocation due to increased demand. • West-Ward did not provide a reason for the shortage. • Etoposide phosphate powder for injection (Etopophos) is unaffected by this shortage.


• Accord has etoposide 20 mg/mL 5 mL and 25 mL vials on allocation. The 50 mL vials on back order and the company estimates a release date of late-July 2018.

• Fresenius Kabi has etoposide 20 mg/mL 5 mL and 25 mL vials on back order and the company estimates a release date of early-July 2018 for the 5 mL vials and late-July 2018 for the 25 mL vials. Check wholesalers for inventory.

• Teva has Toposar 20 mg/mL 5 mL, 25 mL, and 50 mL vials on allocation. • Hikma has etoposide 20 mg/mL 5 mL and 25 mL vials on back order and the company estimates

release dates of late-July to mid-August 2018 for the 5 mL vials and early-July 2018 for the 25 mL vials. The 50 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=369 Acetylcysteine Oral and Inhalation Solution July 3, 2018 Reason for the Shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.


• Fresenius Kabi has acetylcysteine oral and inhalation solution available. • Pfizer has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014. • Arbor has Cetylev effervescent tablets available. These are for oral use only.


• American Regent has acetylcysteine solution 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has acetylcysteine solution 200 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of late-July 2018. The 100 mg/mL 4 mL and 10 mL vials are on back order and the company estimates a release date of late-July 2018.

• Pfizer has acetylcysteine solution 100 mg/mL 30 mL vials and 200 mg/mL 30 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 Sufentanil Injection July 5, 2018 Reason for the Shortage

• Pfizer has sufentanil injection on shortage due to manufacturing delays. • Akorn has Sufenta injection on shortage due to increased demand for the product. • West-Ward did not provide a reason for the shortage.


• Pfizer has sufentanil 50 mcg/mL 1 mL and 5 mL vials on back order and the company estimates a release date of early-August 2018 for the 1 mL vials and December 2018 for the 5 mL vials.

• Akorn has Sufenta 50 mcg/mL 1 mL, 2 mL, and 5 mL ampules on allocation. • West-Ward has sufentanil 50 mcg/mL 5 mL ampules available with an expiration date of July

2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Sterile Water For Injection - Small Volume Vials July 5, 2018 Reason for the Shortage

• American Regent has limited availability of sterile water for injection. • Fresenius Kabi has sterile water on shortage due to increased demand. • Pfizer has sterile water for injection in vials on shortage due to increased demand.


• American Regent has sterile water for injection 5 mL, 10 mL, and 20 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has sterile water for injection 5 mL, 10 mL, 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of late-August 2018 for the 5 mL vials, late-August 2018 for the 10 mL vials, mid-August 2018 for the 20 mL vials, mid-August 2018 for the 50 mL vials, and late-July 2018 for the 100 mL vials. Check wholesalers for inventory.


• Pfizer has sterile water for injection 10 mL, 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of July 2018 for the 10 mL, 20 mL, and 100 mL vials and August 2018 for the 50 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Potassium Chloride Injection July 5, 2018 Reason for the Shortage

• Baxter has their highly concentrated potassium chloride in sterile water on shortage because a manufacturing facility has been affected by Hurricane Maria. Baxter has removed these products from distribution and they can be purchased directly if they are in stock. Baxter is also adjusting the allocation of these products. Baxter did not provide a reason for the shortage of their other potassium chloride products.

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer has potassium chloride injection on shortage due to increase demand. Pfizer discontinued

2 mEq/mL 250 mL bottles in mid-2018. • ICU Medical has potassium chloride injection on shortage due to increased demand. • ICU Medical discontinued potassium chloride 10 mEq/500 mL in 5% dextrose and 0.225%

sodium chloride in 2018. Estimated Resupply Dates

• Baxter has potassium chloride 20 mEq/1000 mL in lactated ringer's and 5% dextrose on back order and the company cannot estimate a release date.

• Baxter has potassium chloride 40 mEq/100 mL and 20 mEq/50 mL in sterile water bags on back order and the company cannot estimate a release date.

• Fresenius Kabi has potassium chloride 10 mEq/5 mL, 20 mEq/10 mL, 40 mEq/20 mL, and 60 mEq/30 mL vials on back order and the company estimates a release date of mid-July 2018 for the 5 mL vials and 20 mL vials and late-July 2018 for the 10 mL and 30 mL vials.

• ICU Medical has potassium chloride 20 mEq/1000 mL in 0.9% sodium chloride available in limited supply. Potassium chloride 10 mEq/500 mL in 5% dextrose and 0.45% sodium chloride is on back order and the company estimates a release date of early-September 2018.

• Pfizer has potassium chloride 10 mEq/5 mL vials and 40 mEq/20 mL vials available in limited supply. The 20 mEq/10 mL vials are on back order and the company estimates a release date of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=12 Piperacillin and Tazobactam Injection July 5, 2018 Reason for the Shortage

• Apotex temporarily discontinued piperacillin/tazobactam in April 2018. • AuroMedics and Sandoz could not provide a reason for the shortage. • Fresenius Kabi had piperacillin/tazobactam on shortage due to increased demand. • Mylan Institutional launched piperacillin/tazobactam 3.375 gram and 4.5 gram vials in early-

June 2016. • Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays.


• Sagent had piperacillin/tazobactam on shortage due to increased demand. • Sandoz has piperacillin/tazobactam available. • WG Critical Care states the reason for the shortage is increased demand. • FDA in conjunction with SteriMax was allowing temporary importation of

piperacillin/tazobactam 3.375 gram, 4.5 gram, and 40.5 gram vials from Canada. This was being distributed through X-Gen Pharmaceuticals. These are no longer being imported with the launch of the products from X-Gen. The product codes on these items will not be recognized by U.S. systems so institutions will need to implement alternative plans to assure the dose is being given correctly. More information can be found on the FDA site at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM543149.pdf.

• Wockhardt has piperacillin/tazobactam injection available. • X-Gen has piperacillin/tazobactam injection available.


• Apotex has temporarily discontinued all piperacillin/tazobactam presentations. • Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back

order and the company estimates a release date of 2019. Pfizer has piperacillin/tazobactam 3.375 gram and 4.5 gram ADD-Vantage vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158 Penicillin G Procaine Injection July 5, 2018 Reason for the Shortage

• Pfizer has penicillin G procaine on shortage due to manufacturing delays. • Pfizer is the sole supplier of penicillin G procaine.


• Pfizer has penicillin G procaine 600,000 unit/mL 1 mL and 2 mL vials on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=240 Oxacillin Sodium Injection July 5, 2018 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Baxter had oxacillin on shortage due to manufacturing delays. • Sagent had oxacillin on shortage due to manufacturing delays.


• AuroMedics has all oxacillin presentations on long-term back order and the company cannot estimate a release date.



Metronidazole Hydrochloride Injection July 5, 2018 Reason for the Shortage

• Pfizer has metronidazole injection on shortage due to manufacturing delay. • BBraun did not provide a reason for the metronidazole injection shortage.


• BBraun has metronidazole 100 mL bags on allocation to current customers. • Pfizer has metronidazole 100 mL bags in 24 count and 80 count on back order and the company

estimates a release date of July 2018 for both presentations. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316 Metoclopramide Injection July 5, 2018 Reason for the Shortage

• Pfizer has metoclopramide injection on shortage due to increased demand. • Teva has metoclopramide injection on shortage due to increased demand. • Fresenius Kabi has metoclopramide injection on shortage due to increased demand.


• Pfizer has metoclopramide 5 mg/mL 2 mL vials available in limited supply. • Teva has metoclopramide 5 mg/mL 2 mL vials on allocation. • Fresenius Kabi has metoclopramide 5 mg/mL 2 mL syringes on back order and the company

estimates a release date of mid-September 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=338 Mepivacaine Injection July 5, 2018 Reason for the Shortage

• Fresenius Kabi had Polocaine and Polocaine-MPF available. • Pfizer states the reason for the shortage is manufacturing delays.


• Fresenius Kabi has 1% Polocaine-MPF 30 mL vials, 1.5% Polocaine-MPF 30 mL vials, and 2% Polocaine-MPF 20 mL vials on back order and the company estimates a release date of late-August 2018.

• Pfizer has 2% Carbocaine 20 mL preservative-free vials, 1% Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Leucovorin Calcium Injection July 5, 2018 Reason for the Shortage


• Fresenius Kabi did not provide a reason for the current shortage. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available. • West-Ward did not provide a reason for the current shortage.


• Fresenius Kabi has leucovorin 200 mg vials on back order and the company expects a release date of mid-July 2018.

• West-Ward has leucovorin 200 mg and 350 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Gentamicin Sulfate Ophthalmic Ointment July 5, 2018 Reason for the Shortage

• Akorn has Gentak ophthalmic ointment on back order with no estimated release date. • Gentamicin ophthalmic solutions are not affected by this shortage.


• Akorn has Gentak 3.5 gram tubes on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=412 Fluorescein Sodium Ophthalmic Strips July 5, 2018 Reason for the Shortage

• Hub did not provide a reason for the shortage. • Akorn did not provide a reason for the shortage.


• Akorn has Ful-Glo 0.6 mg and 1 mg strips on allocation. • Hub has Bio-Glo 1 mg strips on back order and the company estimates a release date of mid-July

2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Dorzolamide Ophthalmic Solution July 5, 2018 Reason for the Shortage

• Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays. • Merck did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage. • Teva discontinued dorzolamide ophthalmic solution in April 2018. • Valeant has dorzolamide ophthalmic solution on shortage due to manufacturing delays.


• Akorn has dorzolamide 2% ophthalmic solution on allocation.


• Valeant has dorzolamide 2% ophthalmic solution temporarily unavailable and the company cannot estimate a release date.

• Sandoz has dorzolamide 2% ophthalmic solution on back order and the company estimates a release date of mid-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359 Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution July 5, 2018 Reason for the Shortage

• Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.

• Sandoz did not provide a reason for the shortage. • Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018. • Valeant has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing


• Akorn has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on allocation. • Valeant has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back

order and the company estimates a release date of early-August 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=360 Diclofenac 0.1% Ophthalmic Solution July 5, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Rising pharmaceuticals discontinued diclofenac ophthalmic solution. • Sandoz did not provide a reason for the shortage.


• Akorn has diclofenac 0.1% ophthalmic solution on long-term back order. • Sandoz has diclofenac 0.1% ophthalmic solution in 2.5 mL and 5 mL bottles on back order and

the company estimates a release date of mid-August 2018 for the 2.5 mL bottles and mid-July 2018 for the 5 mL bottles.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=395 Ciprofloxacin Injection July 5, 2018 Reason for the Shortage

• Pfizer has ciprofloxacin injection on shortage due to manufacturing delays. • Baxter (formerly Claris) has ciprofloxacin injection available.


• Pfizer has ciprofloxaxin 2 mg/mL 100 mL and 200 mL premixed bags on back order and the company estimates a release date of August 2018.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=396 Ceftriaxone Sodium Injection July 5, 2018 Reason for the Shortage

• Apotex has ceftriaxone available. • Fresenius Kabi states the reason for the shortage is increased demand. • Pfizer has ceftriaxone injection on shortage due to increased demand and manufacturing delays. • Sagent states the reason for the shortage is manufacturing delay. • Sandoz has most ceftriaxone presentations available. • West-Ward states the reason for the shortage is manufacturing delay. • Wockhardt relaunched their ceftriaxone presentations in October 2017.


• Fresenius Kabi has ceftriaxone 2 gram vials available with a short expiration date (< 8 months). • Lupin has all ceftriaxone presentations on allocation. • Pfizer has ceftriaxone 500 mg vials, 1 gram ADD-Vantage vials, and 2 gram ADD-Vantage vials on

allocation. The 10 gram vials are on back order and the company estimates a release date of 2019.

• Sagent has ceftriaxone 2 gram and 10 gram vials on back order and the company estimates a release date of July 2018.

• Wockhardt has all ceftriaxone presentations on back order and the company cannot estimate a release date.

• West-Ward has ceftriaxone 500 mg vials on back order and the company cannot estimate a release date. The 2 gram vials are also on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=86 Cefotaxime Sodium Injection July 5, 2018 Reason for the Shortage

• Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

• Baxter discontinued Claforan in late-2015. • West-Ward has cefotaxime on shortage due to manufacturing and issues with raw material.


• West-Ward has cefotaxime 500 mg, 1 gram, 2 gram, and 10 gram vials on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=51 Cefepime Injection July 5, 2018 Reason for the Shortage

• Apotex did not provide a reason for the shortage. • Baxter had cefepime on shortage due to increased demand.


• BBraun has cefepime on shortage due to increased demand. • Fresenius Kabi had cefepime injection on shortage due to manufacturing delays. • Pfizer has Maxipime on shortage due to manufacturing delays. • Sagent had cefepime injection on shortage due to manufacturing delays. • Sandoz discontinued cefepime injection in early-2016. • WG Critical Care had cefepime injection on shortage due to increased demand.


• BBraun has cefepime 1 gram and 2 gram premixed bags on allocation to current customers. • Pfizer has Maxipime 1 gram vials, 2 gram vials, 1 gram ADD-Vantage vials, and 2 gram ADD-

Vantage vials on back order and the company estimates a release date of 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Alcohol Dehydrated Injection (Ethanol) July 5, 2018 Reason for the Shortage

• Akorn states the back order was due to manufacturing delays. • Flon Laboratories has dehydrated alcohol 1 mL and 5 mL vials available through Morris and

Dickson and direct orders. The customer service number is 877-358-4342. It is being marketed by MHC Pharma, LLC.


• American Regent has dehydrated alcohol 1 mL and 5 mL ampules on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=274 Rocuronium Injection July 6, 2018 Reason for the Shortage

• Fresenius Kabi has rocuronium on shortage due to delay of raw materials. • Pfizer has rocuronium on shortage due to manufacturing delays. • Sagent had rocuronium on shortage due to increased demand. • AuroMedics launched rocuronium in mid-2017.


• AuroMedics has rocuronium 10 mg/mL 10 mL vials on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Prothrombin Complex Concentrate (Kcentra) July 6, 2018 Reason for the Shortage

• CSL Behring had short-term delays in product releases.[1] Estimated Resupply Dates


• CSL Behring is releasing Kcentra weekly.[1] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=404 Potassium Acetate Injection July 6, 2018 Reason for the Shortage

• American Regent has not had product available for several years. It is unclear if they will market potassium acetate again in the future.

• Pfizer has potassium acetate on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has potassium acetate 2 mEq/mL 20 mL and 50 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Magnesium Sulfate Injection July 6, 2018 Reason for the Shortage

• American Regent has had magnesium sulfate unavailable since late 2012. • Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for the

product. • Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. • X-Gen discontinued magnesium sulfate in April 2018. • Exela launched magnesium sulfate vials in May 2108.


• Fresenius Kabi has magnesium sulfate 500 mg/mL 2 mL, 10 mL, 20 mL and 50 mL vials on back order and the company estimates a release date of early- to mid-July 2018 for the 2 mL and 50 mL vials, late-July 2018 for the 10 mL vials, and mid-August 2018 for the 20 mL vials. The 40 mg/mL 50 mL and 100 mL premixed bags are on back order and the company estimates a release date of early- to mid-July 2018. The 40 mg/mL 500 mL premixed bags are on back order and the company estimates a release date of mid-July 2018. The 40 mg/mL 1000 mL premixed bags are on back order and the company estimates a release date of late-August 2018. The 10 mg/mL 100 mL premixed bags are on back order and the company cannot estimate a release date.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of September 2018. The magnesium sulfate 10 mg/mL 100 mL bags are on back order and the company estimates a release date of July 2018. The magnesium sulfate 40 mg/mL 50 mL, 100 mL, and 500 mL bags are on back order and the company estimates a release date of August 2018. The 80 mg/mL 50 mL bags are on back order and the company estimates a release date of September 2018.



Lorazepam Oral Solution July 6, 2018 Reason for the Shortage

• Shortage reasons were not provided. Estimated Resupply Dates

• Hikma has lorazepam 2 mg/mL 30 mL bottles on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=386 Lorazepam Injection July 6, 2018 Reason for the Shortage

• Bedford discontinued lorazepam injection in May, 2011.[1] • Hikma has product on shortage due to manufacturing delays.[2] • Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.[3] • Akorn has not provided a reason for the shortage.[4] • Amphastar has product available.[5]


• Hikma has lorazepam 2 mg/mL 10 mL vials on back order and the company estimates a release date of mid- to late-July 2018. The 4 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of mid- to late-July 2018 for the 1 mL vials and August to September 2018 for the 10 mL vials.[2]

• Hikma has Ativan 2 mg/mL 1 mL and 10 mL vials on back order and the company estimates a release date of August to September 2018. Ativan 4 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of mid- to late-July 2018.2

• Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of July 2018. The 2 mg/mL 10 mL vials are on back order and the company estimates a release date of September 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of July 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2019.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Lidocaine With Epinephrine Injection July 6, 2018 Reason for the Shortage

• Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

• Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 0.5% Xylocaine with epinephrine (1:200,000) 50 mL vials on back order and the company cannot estimate a release date. The 1% Xylocaine with epinephrine (1:200,000) 10 mL vials are on back order and the company cannot estimate a release date. The 1% Xylocaine


with epinephrine (1:200,000) 20 mL and 50 mL vials are on back order and the company estimates release dates of late-July 2018 for the 20 mL vials and mid-July 2018 for the 50 mL vials. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company cannot estimate a release date. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 10 mL regular vials and 30 mL vials are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL and 50 mL vials are on back order and the company estimates a release date of mid-July 2018. The 2% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of late-August 2018. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL and 50 mL vials on back order and the company estimates a release date of July 2018. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of August 2018. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of October 2018. The 2% lidocaine with epinephrine (1:100,000) 20 mL and 50 mL vials are on back order and the company estimates a release date of July 2018 for the 20 mL vials and August 2018 for the 50 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Levetiracetam Injection July 6, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Athenex has product available. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has product available. • Mylan has product available. • Pfizer has product available. • Sagent has product available. • Sun Pharma did not provide a reason for the shortage. • UCB has product available. • Hikma has product available. • X-Gen has product available.


• American Regent has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.

• AuroMedics has levetiracetam 5 mg/100 mL, 10 mg/mL 100 mL, and 15 mg/mL 100 mL premixed bags back order and the company cannot estimate a release date.

• Sun Pharma has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.



Indomethacin Capsules July 6, 2018 Reason for the Shortage

• Camber did not provide a reason for the shortage. • Glenmark has indomethacin on shortage due to manufacturing delays. • Heritage discontinued all indomethacin presentations in early-2018. • Mylan did not provide a reason for the shortage. Mylan is in the process of discontinuing all

presentations. • Sandoz discontinued indomethacin in mid-2016. • Teva discontinued all indomethacin presentations in mid-2018.


• Camber has indomethacin 25 mg in 100 count and 50 mg in 100 count on back order and the company estimates a release date of mid-July 2018.

• Glenmark has indomethacin 25 mg in 1000 count and 50 mg in 500 count on back order and the company estimates a release date of mid-July 2018 for the 25 mg in 1000 count and cannot estimate a release date for the 50 mg in 500 count presentations.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=235 Famotidine Injection July 6, 2018 Reason for the Shortage

• Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1] • Hikma did not provide a reason for the shortage.[2] • Pfizer launched famotidine injections in March 2012.[3] • Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.[4] • Fresenius Kabi did not provide a reason for the shortage.[5] • Baxter has famotidine premixed bags available.[6]


• Fresenius Kabi has famotidine 2 mL vials on intermittent back order with regular releases. The 4 mL and 20 mL vials are on back order and the company estimates a release date in late-July to early-August 2018 for the 4 mL vials and early-August 2018 for the 20 mL vials. Check wholesalers for inventory.[5]

• Mylan Institutional has famotidine 2 mL, 4 mL, and 20 mL vials on back order and the company estimates a release date of late-August 2018.[4]

• Hikma has famotidine 4 mL and 20 mL vials on back order and the company estimates a release date of mid- to late-July 2018. The 2 mL vials are on allocation.[2]

, https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166 Dexrazoxane Injection July 6, 2018 Reason for the Shortage

• Cumberland Pharmaceuticals relaunched Totect in late-July 2017. • Mylan Institutional has dexrazoxane available.


• Pfizer states manufacturing delay as the reason for the shortage. • West-Ward has dexrazoxane available.


• Pfizer has Zinecard 250 mg vials on allocation. The 500 mg vials are on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Dexamethasone Sodium Phosphate Injection July 6, 2018 Reason for the Shortage

• American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays.

• AuroMedics has dexamethasone sodium phosphate on intermittent back order. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional has dexamethasone sodium phosphate available. • Hikma did not provide a reason for the shortage.


• American Regent has dexamethasone sodium phosphate 4 mg/mL products on back order and the company cannot estimate a release date.

• AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 4th quarter 2018. The 4 mg/mL 30 mL vials are on back order and the company estimates a release date in late-July 2018.

• Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL and 5 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Carbidopa and Levodopa Extended-Release Tablets July 6, 2018 Reason for the Shortage

• Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50 mg/200 mg tablets are on shortage due to problems obtaining active ingredient.

• Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased demand.

• Merck had Sinemet CR on shortage due to increased demand. • Mylan has carbidopa and levodopa extended-release tablets available.


• Accord has carbidopa and levodopa 50 mg/200 mg extended-release tablets on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349


Carbidopa and Levodopa Extended-Release Tablets Butorphanol Tartrate Injection July 6, 2018 Reason for the Shortage

• Pfizer has butorphanol injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has butorphanol 2 mg/mL 1 mL and 2 mL vials on back order and the company estimates a release date of October 2018

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=414 Buprenorphine Hydrochloride Injection July 6, 2018 Reason for the Shortage

• Pfizer has buprenorphine injection on shortage due to manufacturing delays. • Par had buprenorphine injection on shortage due to increased demand.

Available Products

• Buprenex injection, Indivior, 0.3 mg/mL, 1 mL ampule, 1 count, NDC 12496-0757-01 • Buprenex injection, Indivior, 0.3 mg/mL, 1 mL ampule, 5 count, NDC 12496-0757-05 • Buprenorphine injection, Par Pharmaceuticals, 0.3 mg/mL, 1 mL vial, 5 count, NDC 42023-0179-

05 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419 Ampicillin Sodium and Sulbactam Sodium Injection July 6, 2018 Reason for the Shortage

• Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials. These are on shortage due to manufacturing delays.

• Sagent had ampicillin sulbactam vials on back order due to manufacturing delays. • Sandoz cannot provide a reason for the shortage. • WG Critical Care states the shortage was due to increased demand.


• AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

• Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

• Mylan Institutional has ampicillin sulbactam 1.5 gram and 15 gram vials on back order and the company estimates a release date of mid-July 2018 for the 1.5 gram vials and late-July 2018 for the 15 gram vials.

• Pfizer has ampicillin sulbactam 1.5 gram and 3 gram ADD-Vantage vials available in limited supply.

• Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials temporarily unavailable and the company cannot estimate a release date.


• West-Ward has ampicillin sulbactam 3 gram vials on allocation. The 1.5 gram and 15 gram vials are on back order and the company estimates a release date of August to September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 50% Dextrose Injection July 6, 2018 Reason for the Shortage

• Amphastar has 50% dextrose injection available. • Pfizer has 50% dextrose injection on shortage due to manufacturing delays.


• Pfizer has 50% dextrose 50 mL LifeShield syringes available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 14.6% Sodium Chloride Concentrated Solution For Injection July 6, 2018 Reason for the Shortage

• Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to manufacturing delays.


• Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL and 40 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has 14.6% sodium chloride concentrated solution for injection 40 mL vials on back order and the company estimates a release date of late-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416 Sterile Talc July 9, 2018 Reason for the Shortage

• Lymol has Sclerosol and talc powder on shortage due to manufacturing delays.[1] • Novatech SA has Steritalc powder available.[2]


• Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate a release date.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=260 Recombinant Zoster Vaccine (Shingrix) July 9, 2018 Reason for the Shortage

• GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates


• GlaxoSmithKline has Shingrix kits in 1 count and 10 count on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Liotrix (Levothyroxine/Liothyronine T4/T3) July 9, 2018 Reason for the Shortage

• Thyrolar tablets from Actavis (formerly Forest) are on shortage due to manufacturing changes. Estimated Resupply Dates

• Actavis (formerly Forest) has all Thyrolar presentations on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=131 Hepatitis B Vaccine (Recombinant) July 9, 2018 Reason for the Shortage

• Merck has Recombivax HB on shortage due to increase in global demand. • GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.


• Merck has Recombivax HB adult formulation vials and syringes on back order and the company estimates this will continue through 2018.

• Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent vials on back order and the company estimates this will continue through 2018. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

• Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2018.

• GlaxoSmithKline has Engerix-B adult 20 mcg/mL 1 mL syringes on back order and the company estimates a release date in mid-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Granisetron Hydrochloride Injection July 9, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.


• Akorn has granisetron 1 mg/mL 1 mL vials on back order and product will be allocated upon release. The 4 mL vials are on allocation.

• Fresenius Kabi has granisetron injection 1 mg/mL 1 mL and 4 mL vials on back order and the company estimates a release date in early- to mid-July 2018.


• Hikma has granisetron injection 1 mg/mL 1 mL and 4 mL vials on back order and the company estimates a release date in early- to mid-July 2018 for the 1 mL vials and mid- to late-July 2018 for the 4 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=428 Doxorubicin Injection July 9, 2018 Reason for the Shortage

• Hikma has Adriamycin available.[1] • Teva has doxorubicin solution for injection on shortage due to increased demand.[2-3] • Fresenius Kabi has doxorubicin solution for injection available.[4] • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5] • Pfizer has doxorubicin on shortage due to manufacturing delays.[6] • Sagent discontinued doxorubicin solution for injection in late-2017.[7] • Mylan Institutional has doxorubicin lyophilized powder for injection available.[8] • Athenex has doxorubicin available.[9] • FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg

vials. These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the imported product is different from the US version. FDA has the Dear Healthcare Professional Letter linked on their website. The letter includes a link to both the US and United Kingdom package inserts to help explain the differences in labeling and packaging. The link to the letter is http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be done directly with Hospira Customer Care at 877-946-7747.[10-11]


• Mylan Institutional has doxorubicin lyophilized powder 10 mg vials on back order and the company cannot estimate a release date. The 50 mg vials are available with an expiration date of January 2019.[8]

• Teva has doxorubicin 2 mg/mL 10 mL vials (NDC 45963-0733-57) on back order and the company will allocate these as they become available.[2]

• Hikma has Adriamycin 2 mg/mL 5 mL with short expiration dating (expiry July 2018). The 10 mL vials also have short expiration dating (expiry June 2019 and July 2018).[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Amiodarone Injection July 9, 2018 Reason for the Shortage

• Baxter has Nexterone premixed bags on shortage due to manufacturing delays. • Mylan Institutional did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.


• Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date in mid-July 2018. The 50 mg/mL 18 mL vials are on back order and the company estimates a release date in late-July 2018.

• Hikma has amiodarone 50 mg/mL 3 mL in 10 count available with an expiry of December 2018.


• Baxter has Nexterne on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Amino Acids In Dextrose July 9, 2018 Reason for the Shortage

• Baxter has all Clinimix presentations on allocation due to delays because of the hurricane in Puerto Rico.

• Baxter has reintroduced Clinimix into the distribution channel. Estimated Resupply Dates

• Baxter has all Clinimix presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=355 Amino Acid Products with Electrolytes and Calcium July 9, 2018 Reason for the Shortage

• Baxter has all Clinimix E with electrolytes plus calcium presentations on allocation due to delays because of the hurricane in Puerto Rico.

• Baxter has reintroduced Clinimix into the distribution channel. • To help alleviate the critical drug shortages resulting from the aftermath of Hurricane Maria,

FDA has allowed Baxter to temporarily import the following amino acid products: Clinimix N9G15E, Clinimix N9G20E, and Clinimix N14G30E solutions for infusion. Additional information can be found in the Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584414.pdf


• Baxter has all amino acid products with electrolytes plus calcium on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=354 Mineral Oil and Petrolatum Ophthalmic Ointment July 11, 2018 Reason for the Shortage

• Allergan did not provide a reason for the shortage. • Major did not provide a reason for the shortage. • Rugby did not provide a reason for the shortage. • Valeant did not provide a reason for the shortage.


• Allergan has mineral oil/petrolatum 42.5%/57.3% 3.5 g tubes on back order and the company cannot estimate a release date. The 42.5%/56.8% 3.5 g and 7 g tubes are also on back order and the company cannot estimate a release date.

• Major has mineral oil/petrolatum 15%/83% 3.5 g tubes on back order and the company cannot estimate a release date.


• Rugby has mineral oil/petrolatum 15%/83% 3.5 g tubes on back order and the company cannot estimate a release date.

• Novartis has mineral oil/petrolatum 15%/85% 3.5 g tubes on back order and the company estimates a release date of late-July 2018.

• Perrigo has mineral oil/petrolatum 15%/85% 3.5 g and 1 g tubes on back order and the company estimates release dates of August 2018.

• Valeant has mineral oil/petrolatum 20%/80% 3.5 g tubes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Methocarbamol Tablets July 11, 2018 Reason for the Shortage

• Bayshore, Par, Solco, Virtus, Hikma, and Endo did not provide a reason for the shortage. • Camber states the shortage is due to an API shortage.


• Camber has all methocarbamol tablets on intermittent back order and is shipping product weekly.

• Par has all methocarbamol tablets on back order and the company cannot estimate a release date.

• Solco has methocarbamol 500 mg tablets in 100 count and 500 count and 750 mg tablets in 100 count and 500 count on allocation.

• Virtus has all methocarbamol tablets on back order and the company estimates a release date of August 2018.

• Hikma has methocarbamol 750 mg tablets in 100 count and 500 count on back order and the company cannot estimate a release date.

• Endo has Robaxin 500 mg tablets in 100 count on back order and the company estimates a release date of late-August 2018.

• Bayshore has methocarbamol 500 mg tablets in 100 count and 500 count and 750 mg tablets in 500 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Bacteriostatic 0.9% Sodium Chloride Vials July 11, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer has bacteriostatic sodium chloride vials on shortage due to manufacturing delays.


• Fresenius Kabi has bacteriostatic 0.9% sodium chloride 30 mL vials on back order and the company cannot estimate a release date.

• Pfizer has bacteriostatic 0.9% sodium chloride 10 mL, 20 mL, and 30 mL vials on back order and the company estimates a release date of August 2018 for the 10 mL and 20 mL vials and September 2018 for the 30 mL vials.



0.9% Sodium Chloride Small Volume Bags (< 150 Ml) July 11, 2018 Reason for the Shortage

• Baxter has 0.9% sodium chloride small volume bags on shortage due to manufacturing delays. • BBraun has 0.9% sodium chloride small volume bags on shortage due to increased demand. • ICU Medical has 0.9% sodium chloride small volume bags on shortage due to increased demand.


• Baxter has all 0.9% sodium chloride small volume bags on allocation. • BBraun has all 0.9% sodium chloride small volume bags on allocation to current customers only. • Pfizer has 0.9% sodium chloride 50 mL Add-Vantage bags and 100 mL Add-Vantage bags on back

order and the company estimates a release date in July 2018. The 50 mL preservative-free vials are also on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Lactated Ringer's Injection July 12, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun states the reason for the shortage is increased demand. • ICU Medical states the reason for the shortage is increased demand.


• Baxter has lactated ringer's 250 mL, 500 mL, and 1000 mL bags on allocation. Lactated ringer's with 5% dextrose 500 mL and 1000 mL bags are also on allocation.

• BBraun has lactated ringer's injection solution and lactated ringer's with 5% dextrose injection solution products on allocation to current customers.

• ICU Medical has lactated ringer's 500 mL bags on back order and the company estimates a release date in early-August 2018. Lactated ringer's with 5% dextrose 1000 mL bags are also on back order and the company estimates a release date in late-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=361 Ketorolac Injection July 12, 2018 Reason for the Shortage

• Alvogen has ketorolac injection available in 25 count sizes.[1] • Amphastar did not provide a reason for the shortage.[2] • Athenex has ketorolac injection available.[3] • BD RX is now part of Fresenius Kabi.[4] • Fresenius Kabi has ketorolac available.[5] • Pfizer has ketorolac injection on back order due to manufacturing delays.[6] • Sagent states the reason for the shortage is manufacturing delay.[7] • Hikma did not provide a reason for the shortage.[8] • Ben Venue closed its plant in Bedford, Ohio in July 2014.[9]


• Virtus has ketorolac injection available.[10] • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.[11] • Sprix Nasal Spray is not affected by this shortage.[12]


• Alvogen has 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order with unknown release dates.1

• Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date.[2]

• Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes, 30 mg/mL 2 mL Carpuject syringes for intramuscular injection, and 30 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of 2019. The 15 mg/mL 1 mL vials are available in limited supply.[6]

• Sagent has all ketorolac products on back order. The company estimates release dates of July 2018 for the 30 mg/mL 1 mL vials. The company cannot estimate a release date for the 15 mg/mL 1 mL vials or the 30 mg/mL 2 mL vials for intramuscular injection.[7]

• Hikma has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of August to September 2018. The 30 mg/mL 1 mL vials and 30 mg/mL 2 mL vials for intramuscular injection are on allocation.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Chlorothiazide Sodium Injection July 12, 2018 Reason for the Shortage

• Akorn has chlorothiazide injection on shortage due to manufacturing delays. • Sagent had chlorothiazide injection on shortage due to increased demand. • Sun Pharma refuses to provide availability information on any of their products.


• Akorn has chlorothiazide 500 mg vials on allocation. • Akorn has Sodium Diuril 500 mg vials on allocation. • American Regent has chlorothiazide 500 mg vials on allocation. • Mylan Institutional has chlorothiazide 500 mg vials available. • Sun Pharma has chlorothiazide 500 mg vials on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=365 Amino Acid Products July 12, 2018 Reason for the Shortage

• Baxter has reintroduced amino acids into the distribution channel.[1] • Baxter has most amino acid products on allocation due to delays because of Hurricane Maria in

Puerto Rico. • BBraun has discontinued FreAmine HBC, Nephramine, and Trophamine 6%.[2] • ICU Medical has Aminosyn on back order due to an ingredient shortage which has caused a

supply disruption.[3]


Estimated Resupply Dates • Baxter has their amino acid products on allocation.[1] • ICU Medical has Aminosyn 3.5% 1000 mL bags, Aminosyn 8.5% 500 mL and 500 mL with

electrolytes bags, Aminosyn 10% 500 mL and 1000 mL bags, Aminosyn II 8.5% 500 mL and 500 mL with electrolytes bags, and Aminosyn II 10% 500 mL and 1000 mL bags on back order and the company estimates a release date of 1st quarter 2019.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=297 Vancomycin Hydrochloride Injection July 13, 2018 Reason for the Shortage

• Athenex has vancomycin injection available.[1] • Pfizer has vancomycin vials on back order due to manufacturing delays.[2] • Fresenius Kabi has vancomycin injection on shortage due to increased demand.[3] • Mylan Institutional has vancomycin injection available.[4] • Sagent has vancomycin injection on shortage due to manufacturing delays and increased

demand.[7] • Baxter has vancomycin injection available.[5] • Samson Medical Technologies has vancomycin injection available.[6]


• Fresenius Kabi has vancomycin 750 mg, 5 gram and 10 gram vials on intermittent back order with regular releases.3

• Pfizer has vancomycin 500 mg vials, 500 mg ADD-Vantage vials, 1 gram vials, and 1 gram ADD-Vantage vials on back order and the company estimates release dates of July 2018. The 750 mg and 5 gram vials are on back order and the company estimates release dates of August 2018. The 750 mg ADD-Vantage vials on back order and the company estimates a release date of October 2018. The 10 gram vials are on back order and the company cannot estimate a release date.[2]

• Sagent has vancomycin 5 gram and 10 gram vials on back order and the company estimates release dates of July 2018.[7]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Hypromellose Ophthalmic Solution July 13, 2018 Reason for the Shortage

• Akorn has hypromellose ophthalmic solution on shortage due to lack of raw materials.1 • HUB Pharmaceuticals has hypromellose ophthalmic solution on long-term back order and did

not provide a reason.2 Estimated Resupply Dates

• Akorn has hypromellose 2.5% ophthalmic solution 15 mL bottles on back order and the company estimates a release date of August 2018.1

• HUB Pharmaceuticals has hypromellose 2.5% ophthalmic solution 15 mL bottles on long-term back order and the company cannot estimate a release date.2



Hydromorphone Hydrochloride Injection July 13, 2018 Reason for the Shortage

• Akorn has hydromorphone injection on shortage due to increased demand.[1] • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing

their product on the 0.5 mg strength. The launched hydromorphone vials in late-June 2018.[2] • Pfizer did not provide a reason for the shortage.[3] • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4] • Teva did not provide a reason for the shortage.[5] • West-Ward did not provide a reason for the shortage.[6]


• Akorn has hydromorphone 10 mg/mL 1 mL ampules, 5 mL ampules, and 50 mL vials on intermittent back order and the company is allocating product upon release.[1]

• Fresenius Kabi has Dilaudid 0.5 mg/mL 0.5 mL and 1 mg/mL 1 mL syringes on back order and the company estimates a release date of mid-July 2018. The 2 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date.[2]

• Hikma has hydromorphone 2 mg/mL 1 mL vials on allocation. The 20 mL vials are on back order and the company estimates a release date of mid-August 2018.[6]

• Pfizer has 2 mg/mL 1 mL vials on back order and the company estimates a release date of September 2018. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-July 2018. The 10 mg/mL 5 mL vials are on back order and the company estimates a release date of late-August 2018. The 10 mg/mL 50 mL vials are on back order and the company estimates a release date of November 2018. The 1 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of July 2018. The 2 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2019. The 0.5 mg/0.5 mL 0.5 mL iSecure syringes are on back order and the company estimates a release date of March 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company cannot estimate a release date. The 1 mg/mL 1 mL iSecure syringes, 2 mg/mL 1 mL iSecure syringes, and 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019.[3]

• Teva has hydromorphone 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is allocating product upon release.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Scopolamine Transdermal System July 17, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • GlaxoSmithKline has Transderm Scop patches available. • Perrigo did not provide a reason for the shortage.


• Baxter has Transderm Scop patches on allocation.


• Perrigo has scopolamine patches on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=442 Phenytoin Sodium July 17, 2018 Reason for the Shortage

• West-Ward did not provide a reason for this shortage. • X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.


• West-Ward has phenytoin sodium 50 mg/mL 2 mL vials and 50 mg/mL 5 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406 Norepinephrine Bitartrate Injection July 17, 2018 Reason for the Shortage

• Baxter (formerly Claris) did not provide a reason for the shortage. • Pfizer has Levophed on shortage due to manufacturing delays. • Teva has norepinephrine injection on allocation due to increased demand.


• Baxter has norepinephrine 1 mg/mL 4 mL ampules on back order and the company estimates a release date in late-July 2018.

• Pfizer has Levophed 1 mg/mL 4 mL ampules on back order and the company estimates a release date of 2020.

• Teva has norepinephrine 1 mg/mL 4 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Morphine Injection July 17, 2018 Reason for the Shortage

• Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.[1-2]

• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.[2]

• Pfizer states the shortage is due to manufacturing delays. Pfizer discontinued morphine ADD-Vantage vials in January 2017.[3]

• Pfizer anticipates a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018.[3]

• West-Ward did not provide a reason for the shortage. West-Ward is not actively marketing the 15 mg/mL 1 mL vials or the 8 mg/mL 1 mL vials (NDC 00641-6075-25). They are still marketing the 8 mg/mL 1 mL vials with NDC 00641-6126-25.[4]



• Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a release date of early-August 2018. The morphine 4 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The morphine 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL vials and 4 mg/mL 1 mL vials are on back order and the company estimates a release date of early-August 2018. The 5 mg/mL 1 mL vials, 8 mg/mL 1 mL vials, and 10 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-August 2018. Check wholesalers for inventory.[2]

• Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of July 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 50 mg/mL 20 mL vials are on back order and the company estimates a release date of August 2018. The 50 mg/mL 50 mL vials are available in limited supply.[3]

• West-Ward has morphine 4 mg/mL 1 mL vials and 10 mg/mL 1 mL vials on allocation. The 8 mg/mL 1 mL vials are on back order and the company estimates a release date of August to September 2018. Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules are on back order and the company cannot estimate a release date. Duramorph 1 mg/mL 10 mL ampules are on allocation. Duramorph 0.5 mg/mL 10 mL ampules are on allocation.[4]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Meperidine Hydrochloride Injection July 17, 2018 Reason for the Shortage

• Pfizer has Demerol injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release date of March 2019. The 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, 75 mg/mL 1 mL Carpuject syringes, and 100 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2019. The 50 mg/mL 0.5 mL ampules are on back order and the company estimates a release date of early-August 2018. The 50 mg/mL 1 mL ampules are on back order and the company estimates a release date of July 2018.The 50 mg/mL 2 mL ampules are on back order and the company estimates a release date of August 2018. The 50 mg/mL 30 mL vials are on back order and the company estimates a release date of late-August 2018.

• West-Ward has 25 mg/mL 1 mL vials and 50 mg/mL 1 mL vials on allocation. The 100 mg/mL 1 mL vials are on back order and the company estimates a release date of August to September 2018.



Lidocaine Hydrochloride and 5% Dextrose Injection July 17, 2018 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun did not provide a reason for the shortage.


• BBraun has lidocaine and 5% dextrose 4 mg/mL 250 mL, 4 mg/mL 500 mL, and 8 mg/mL 250 mL premixed bags on allocation to contracted customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=372 Ethiodized Oil July 17, 2018 Reason for the Shortage

• Guerbet states their Lipiodol product is in short supply due to manufacturing problems at Jubilant HollisterStier, the manufacturing site in Canada that supplies Lipiodol for Guerbet. The company estimates the shortage will last at least one year.[1-2]


• Guerbet is shipping supplies of Lipiodol Ultra-Fluide.[2] Lipiodol Ultra-Fluide is not FDA approved. In order to prevent a drug shortage, FDA is allowing Guerbet to import Lipiodol Ultra-Fluide, a product manufactured for Guerbet in France by Delpharm Tours.[2]

• Customers must order Lipiodol Ultra-Fluide directly from Guerbet by calling 1-877-729-6679. Lipiodol Ultra-Fluide is non-refundable and may not be resold.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=39 Diazepam Injection July 17, 2018 Reason for the Shortage

• Pfizer has diazepam on shortage due manufacturing delays. Estimated Resupply Dates

• Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Ciprofloxacin Ophthalmic Solution July 17, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Novartis has short-dated product available. • Sandoz did not provide a reason for the shortage.



• Akorn has ciprofloxacin ophthalmic solution on allocation. • Novartis has Ciloxan ophthalmic solution available with an expiration date of June 2019. • Sandoz has ciprofloxacin ophthalmic solution on back order and the company estimates a

release date in late-July 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=443 Azithromycin Injection July 17, 2018 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Pfizer has azithromycin injection on shortage due to manufacturing delays. • Sun Pharma did not provide a reason for the shortage.


• AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing product as it becomes available.

• Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Ranitidine Injection July 18, 2018 Reason for the Shortage

• Teligent has Zantac IV on shortage due to production delays. • Zydus has ranitidine injection on allocation due to increased demand.


• Zydus has ranitidine 25 mg/mL 2 mL and 6 mL vials on allocation. • Teligent has Zantac 25 mg/mL 2 mL vials on back order and the company estimates a release

date of 4th quarter 2018. Zantac 25 mg/mL 6 mL and 40 mL vials are available but are short-dated.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426 Penicillamine July 18, 2018 Reason for the Shortage

• Mylan did not provide a reason for the shortage. Estimated Resupply Dates

• Mylan has Depen tablets available for emergency drop shipment only. The company estimates that more supply will be available mid-February 2019.



Pamidronate Disodium Injection July 18, 2018 Reason for the Shortage

• Areva has pamidronate powder for injection available. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has pamidronate on shortage due to manufacturing delays.


• Mylan Institutional has pamidronate 3 mg/mL and 9 mg/mL 10 mL vials on back order and the company estimates a release date of late-October to early-November 2018.

• Pfizer has pamidronate 9 mg/mL 10 mL vials on back order and the company estimates a release date of July 2018. The 3 mg/mL 10 mL vials are on back order and the company estimates a release date of August 2018. The 6 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=402 Fluorouracil Injection July 18, 2018 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Teva has fluorouracil injection on allocation due to increased demand.


• Accord has fluorouracil 50 mg/mL 20 mL vials on back order and the company estimates a release date of late-July 2018. The 50 mL and 100 mL vials are on back order and the company estimates release dates of mid-July 2018.

• Fresenius Kabi has fluorouracil 50 mg/mL 10 mL vials on back order and the company estimates a release date of mid-July 2018. The 50 mL and 100 mL vials are on back order and the company estimates a release date of late-July 2018.

• Teva has Adrucil 50 mg/mL 10 mL, 50 mL, and 100 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=401 Atropine Ophthalmic Solution July 18, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. Estimated Resupply Dates

• Akorn has atropine ophthalmic solution in 15 mL bottles on back order and the company estimates a release date of early-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=429 Fomepizole Injection July 19, 2018


Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • X-Gen has fomepizole on shortage due to increased demand.


• Mylan Institutional has fomepizole 1 gram/mL 1.5 mL vials on back order and the company estimates a release date of mid-July 2018.

• X-Gen has fomepizole 1 gram/mL 1.5 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=394 Diltiazem Hydrochloride Injection July 19, 2018 Reason for the Shortage

• Akorn states the reason for the shortage was increased demand due to market conditions. • Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. • West-Ward has diltiazem injection on shortage due to manufacturing delays caused by

increased demand due to current market conditions Estimated Resupply Dates

• Akorn has diltiazem 5 mg/mL 5 mL and 25 mL vials on back order and the company estimates release dates of late-July 2018. The 10 mL and 10-count, 25 mL vials are on back order and the company cannot estimate release dates.

• Hikma has diltiazem 5 mg/mL 10 mL and 25 mL vials on allocation. The 5 mL vials are on back order and the company estimates a release date of mid-August to mid-September 2018.

• Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of July 2018. The 5 mg/mL 5 mL and 10 mL vials are on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Valsartan Tablets July 20, 2018 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Major, Solco, and Teva valsartan tablets are affected by the recall. • Alemic, Aurobindo, Cadista, Lupin, Mylan, Macleods, and Novartis are not affected by this recall. • Repackagers may have some presentations affected depending on the source supplier.


• Aurobindo has valsartan tablets on intermittent back order and the company is releasing product as it becomes available.


• Cadista has valsartan tablets on allocation. • Major has valsartan tablets on back order due to the recall and the company cannot estimate a

resupply date. • Teva has valsartan tablets on back order due to the recall and the company cannot estimate a

resupply date. • Solco has valsartan tablets on back order due to the recall and the company cannot estimate a

resupply date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Valsartan and Hydrochlorothiazide Tablets July 20, 2018 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Major, Solco, and Teva valsartan tablets are affected by the recall. • Alemic, Aurobindo, Cadista, Lupin, Mylan, Macleods, and Novartis are not affected by this recall. • Repackagers may have some presentations affected depending on the source supplier.


• Aurobindo has valsartan/hydrochlorothiazide tablets on back order due to the recall and the company cannot estimate a resupply date.

• Cadista has valsartan/hydrochlorothiazide tablets on allocation. • Major has valsartan/hydrochlorothiazide tablets on back order due to the recall and the

company cannot estimate a resupply date. • Mylan has valsartan/hydrochlorothiazide 160mg/12.5mg and 160mg/25mg tablets on back

order and the company estimates a release date in December 2018. • Solco has valsartan/hydrochlorothiazide tablets on back order due to the recall and the

company cannot estimate a resupply date. • Teva has valsartan/hydrochlorothiazide tablets on back order due to the recall and the company

cannot estimate a resupply date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445 Tobramycin Sulfate Injection July 20, 2018 Reason for the Shortage

• Akorn has tobramycin injection on shortage due to manufacturing delays. • Pfizer did not provide a reason for the shortage. • Teva discontinued tobramycin 40 mg/mL 30 mL vials in June 2018.


• Akorn has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date.


• Baxter (formerly Claris) has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date.

• Mylan Institutional has tobramycin 40 mg/mL 2 mL vials on back order and the company estimates a release date of late-August 2018.

• Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials. • Fresenius Kabi has tobramycin 40 mg/mL 2 mL vials on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=164 Sodium Phosphate Injection July 20, 2018 Reason for the Shortage

• American Regent has sodium phosphate injection on shortage due to manufacturing delay. • Fresenius Kabi states the reason for the shortage is increased demand. • Pfizer has sodium phosphate injection on shortage due to manufacturing delay.


• American Regent has sodium phosphate 3 mmol/mL 5 mL, 15 mL, and 50 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has all sodium phosphate presentations available. • Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates

a release date of 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Ropivacaine Injection July 20, 2018 Reason for the Shortage

• Akorn has ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer has ropivicaine on shortage due to manufacturing delays.


• Akorn has ropivacaine 2 mg/mL 30 mL vials on allocation. • AuroMedics has ropivcaine 2 mg/mL 20 mL vials and 100 mL bottles and 10 mg/mL 10 mL and

20 mL vials on intermittent back order and the company is releasing product as it becomes available.

• Pfizer has ropivacaine 2 mg/mL 10 mL vials on back order and the company estimates a release date of October 2018. The 5 mg/mL 30 mL vials are available in limited supply. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of July 2018. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of September 2018.

• Fresenius Kabi has Naropin 2 mg/mL 100 mL and 200 mL bottles on back order and the company estimates a release date of late-July 2018. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of late-July to early-August 2018. The 5 mg/mL 30 mL Steripak ampules are on back order and the company estimates a release date of 3rd quarter


2018. The 7.5 mg/mL 20 mL Steripak ampules are on back order and the company estimates a release date of late-July 2018. The 10 mg/mL 20 mL vials are on back order and the company estimates a release date of late-July to early-August 2018. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Progesterone Injection July 20, 2018 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Fresenius Kabi has progesterone on shortage due to increased demand and manufacturing

delays. • Teva has progesterone on shortage due to supply constraints. • Hikma has progesterone available.


• American Regent has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company cannot estimate a release date.

• Fresenius Kabi has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of late-August 2018.

• Teva has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=381 Nalbuphine Injection July 20, 2018 Reason for the Shortage

• Pfizer has nalbuphine or shortage due to manufacturing delays Estimated Resupply Dates

• Pfizer has nalbuphine 10 mg/mL 1 mL ampules available in limited supply. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=409 Mupirocin Calcium 2% Cream July 20, 2018 Reason for the Shortage

• GlaxoSmithKline is looking for an alternative supply source. • Prasco discontinued mupirocin calcium 2% cream in February 2016.


• GlaxoSmithKline has Bactroban 2% cream in 15 gram and 30 gram sizes on long-term back order and the company cannot estimate a release date.

• Glenmark has mupirocin 2% cream in 15 gram and 30 gram sizes on back order and the company estimates a release date of late-July 2018.



Mitoxantrone Hydrochloride Injection July 20, 2018 Reason for the Shortage

• Fresenius Kabi has mitoxantrone available. • Pfizer has mitoxantrone injection on shortage due to manufacturing delays. • Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily

discontinued. Estimated Resupply Dates

• Fresenius Kabi has mitoxantrone 2 mg/mL 12.5 mL vials available with an expiration date of <8 months.

• Pfizer has mitoxantrone 2 mg/mL 10 mL vials on back order and the company estimates a release date of July 2018.

• Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=189 Magnesium Sulfate Injection July 20, 2018 Reason for the Shortage

• American Regent has had magnesium sulfate unavailable since late 2012. • Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for the

product. • Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. • X-Gen discontinued magnesium sulfate in April 2018. • Exela launched magnesium sulfate vials in May 2.108.


• Fresenius Kabi has magnesium sulfate 500 mg/mL 2 mL, 10 mL, 20 mL and 50 mL vials on back order and the company estimates a release date of late-July 2018 for the 2 mL, 10 mL, and 50 mL vials, and mid-August 2018 for the 20 mL vials. The 40 mg/mL 50 mL and 100 mL premixed bags are on back order and the company estimates a release date of late-July 2018. The 40 mg/mL 500 mL premixed bags are on back order and the company estimates a release date of late-July 2018. The 40 mg/mL 1000 mL premixed bags are on back order and the company estimates a release date of late-August 2018. The 80 mg/mL 50 mL premixed bags are on back order and the company estimates a release date of late-July 2018. The 10 mg/mL 100 mL premixed bags are on back order and the company cannot estimate a release date.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of October 2018. The magnesium sulfate 10 mg/mL 100 mL bags are on back order and the company estimates a release date of August 2018. The magnesium sulfate 40 mg/mL 50 mL, 100 mL, and 500 mL bags are on back order and the company estimates a release date of August 2018. The 40 mg/mL 1000 mL bags are available in limited supply. The 80 mg/mL 50 mL bags are on back order and the company estimates a release date of September 2018.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Leuprolide Acetate 14-Day Kit July 20, 2018 Reason for the Shortage

• Sun Pharma did not provide a reason for the shortage. • Sandoz states the reason for the shortage was increased demand. • Teva states the shortage is due to manufacturing delays.


• Sandoz has leuprolide acetate injection on intermittent back order and the company is releasing product as it becomes available.

• Teva has leuprolide acetate injection on long-term back order and the company cannot estimate a release date.

• Sun Pharma has leuprolide acetate injection on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=81 Fentanyl Citrate Injection July 20, 2018 Reason for the Shortage

• Akorn has fentanyl injection on shortage due to increased demand. • West-Ward has fentanyl injection on shortage due to supply and demand issues. • Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were

discontinued in September 2017. Estimated Resupply Dates

• Akorn has Sublimaze 50 mcg/mL 2 mL ampules in 10 count and 25 count, and 5 mL ampules in 10 count and 25 count on allocation.

• Pfizer has fentanyl 50 mcg/mL 2 mL and 5 mL ampules on back order and the company estimates a release date of August 2018 for the 2 mL ampules and mid-August 2018 for the 5 mL ampules. The 2 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 2 mL, 5 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of August 2018 for the 2 mL vials, early-August 2018 for the 5 mL vials, mid-August 2018 for the 20 mL vials, and early-August 2018 for the 50 mL vials. The 10 mL vials are available in limited supply.

• West-Ward has fentanyl 50 mcg/mL 2 mL, 5 mL, 20 mL, and 50 mL vials on allocation. The 2 mL, 5 mL, and 20 mL ampules are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Dexmedetomidine Hydrochloride Injection July 20, 2018 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Athenex has dexmedetomidine vials available.


• Fresenius Kabi has dexmedetomidine vials available. • Mylan has dexmedetomidine vials available. • Par has dexmedetomidine vials available. • Pfizer did not provide a reason for the shortage. • Sandoz has dexmedetomidine vials available. • Teva has dexmedetomidine vials available. • Hikma did not provide a reason for the shortage.


• Akorn has dexmedetomidine 100 mcg/mL 2 mL vials available with an expiration date of December 2018.

• Hikma has 100 mcg/mL 2 mL vials on back order and the company estimates a release date of late-July 2018.

• Pfizer has Precedex 4 mcg/mL 50 mL and 100 mL premixed bottles on back order and the company estimates a release date of August 2018. The 4 mcg/mL 20 mL vials are on back order and the company estimates a release date in July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=398 Cefpodoxime Oral Suspension July 20, 2018 Reason for the Shortage

• Sandoz has discontinued cefpodoxime oral suspension. • Sun Pharma did not provide a reason for the shortage. • Cefpodoxime tablets are not affected by this shortage.


• Sun Pharma has 50 mg/5mL 100 mL bottles on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=410 Bupivacaine Injection July 20, 2018 Reason for the Shortage

• AuroMedics has not provided a reason for the shortage. • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017. Estimated Resupply Dates

• AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.


• Fresenius Kabi has 0.25% Sensorcaine 10 mL preservative-free vials on back order and the company estimates a release date of late-July 2018. The 0.25% 30 mL preservative-free vials are on back order and the company estimates a release date of late-August 2018. The 0.25% 50 mL vials are on back order and the company estimates a release date of late-July 2018. The 0.5% Sensorcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates release dates of late-July 2018. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of late-July 2018. The 0.75% 30 mL preservative-free vials are on back order and the company estimates a release date of early-August 2018. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.

• Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of September 2018 for the 10 mL vials and November 2018 for the 30 mL vials. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of July 2018. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of 2019 for the 10 mL vials and August 2018 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of August 2018. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of September 2018 for the 10 mL vials and November 2018 for the 30 mL vials. The bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of September 2018.

• Pfizer has all Marcaine presentations on back order and the company estimates a release date of 2019 except for the bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are on back order with an estimated release date of August 2018.

• Baxter has bupivacaine 0.75% in 8.25% dextrose 2 mL ampules on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Methotrexate Injection July 23, 2018 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Fresenius Kabi has methotrexate injection available. • Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued

the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017. • Pfizer has methotrexate injection available. • Teva had methotrexate injection on shortage due to increased demand. • West-Ward has methotrexate injection available.


• Fresenius Kabi has methotrexate 1 gram vials of lyophilized powder for solution on back order and the company estimates a release date of late-July to early-August 2018.

• Pfizer has methotrexate 25 mg/mL 2 mL vials on back order and the company estimates a release date of September 2018.



Iron Dextran Injection July 23, 2018 Reason for the Shortage

• Allergan has INFeD on shortage due to manufacturing delays. • American Regent discontinued Dexferrum injection in 2014.


• Allergan has INFeD 50 mg/mL 2 mL vials on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=408 Hydralazine Injection July 23, 2018 Reason for the Shortage

• Akorn has product on back order due to increased demand. • American Regent did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • X-Gen did not provide a reason for the shortage.


• Akorn has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

• American Regent has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=431 Deferoxamine Injection July 23, 2018 Reason for the Shortage

• Fresenius Kabi has deferoxamine on shortage due to increased demand. • Pfizer has deferoxamine on shortage due to manufacturing delays. • Novartis has Desferal on shortage due to increased demand.


• Fresenius Kabi has deferoxamine 500 mg and 2 gram vials on back order and the company estimates a release date of late-July to early-August 2018. Check wholesalers for inventory.

• Pfizer has deferoxamine 500 mg vials on back order and the company estimates a release date of August 2018.

• Novartis has Desferal 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393


Cefuroxime Sodium Injection July 23, 2018 Reason for the Shortage

• Sagent has cefuroxime injection on shortage due to manufacturing delays. • Teligent discontinued all Zinacef presentations in February 2018. • West-Ward did not provide a reason for the cefuroxime injection shortage.


• Sagent has cefuroxime 750 mg vials on back order and the company cannot estimate a release date.

• West-Ward has cefuroxime 750 mg vials on back order and the company estimates a release date of late-July 2018. The 7.5 gram vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Calcium Gluconate Injection July 23, 2018 Reason for the Shortage

• American Regent has calcium gluconate on shortage due to manufacturing delays. • Fresenius Kabi has calcium gluconate available with alternating short-dating due to

manufacturing process of the vials. Estimated Resupply Dates

• American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has calcium gluconate 100 mg/mL 10 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of early-September 2018 for the 10 mL and 100 mL vials and late-July to early-August 2018 for the 50 mL vials. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=150 Calcium Chloride Injection July 23, 2018 Reason for the Shortage

• American Regent has calcium chloride injection available. • Amphastar has calcium chloride injection available. • Pfizer has calcium chloride on shortage due to manufacturing delays. • Mylan Institutional has withdrawn calcium chloride syringes from the market. The company

recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.


• American Regent has 100 mg/mL 10 mL vials available in limited supply. • Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes and 100 mg/mL 10 mL LifeShield

syringes on back order and the company estimates a release date of August 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48


Bupivacaine with Epinephrine Injection July 23, 2018 Reason for the Shortage

• Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

• Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of late-August 2018. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-July 2018. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-July 2018. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-August 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-July 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-July to early-August 2018. The 0.75% Sensorcaine with epinephrine 30 mL vials are on back order and the company estimates a release date of late-August 2018.

• Pfizer has 0.25% bupivacaine with epinephrine 30 mL preservative-free vials on back order and the company estimates a release date of July 2018. The 0.25% bupivacaine with epinephrine 10 mL preservative-free vials are available in limited supply. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of 2019. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of August 2018. The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019. The 0.5% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of 2019. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Atropine Sulfate Injection July 23, 2018 Reason for the Shortage

• American Regent had atropine injection on shortage due to market demand. • Amphastar has atropine injection available. • Pfizer has atropine injection on shortage due to manufacturing delays. • Hikma has atropine injection available.


Estimated Resupply Dates • Pfizer has atropine 0.1 mg/mL 10 mL Ansyr syringes and 0.1 mg/mL 10 mL LifeShield syringes

available in limited supply. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of July 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 23.4% Sodium Chloride Injection July 23, 2018 Reason for the Shortage

• Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand. • Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.


• Fresenius Kabi has 23.4% sodium chloride 30 mL and 100 mL vials on back order and the company estimates a release date of late-July to early-August 2018 for the 30 mL vials and mid-August 2018 for the 100 mL vials. The 200 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 0.9% Sodium Chloride 10 mL, 20 mL and 50 mL Preservative Free Vials and Syringes July 23, 2018 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing


• Fresenius Kabi has 0.9% sodium chloride preservative free 10 mL and 20 mL vials on back order and the company estimates a release date of mid-August 2018 for the 10 mL vials and late-August 2018 for the 20 mL vials.

• Pfizer has 0.9% sodium chloride preservative free 10 mL LifeShield syringes on back order and the company estimates a release date of September 2018. The 10 mL vials are on back order and the company estimates a release date of July 2018. The 20 mL vials are on back order and the company estimates a release date of October 2018. The 50 mL vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 *Please refer to ASHP website for more information at: http://www.ashp.org/menu/DrugShortages/CurrentShortages/

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