BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

14 04 01 2396 Co-Amoxiclav Rapiclav AAT134009 Blue Global (FZE) 1-Apr-14 Notified

14 04 01 2397 Co-Amoxiclav Rapiclav AAT134010 Blue Global (FZE) 1-Apr-14 Notified

14 04 01 2398 Cefalexin Monohydrate Zelexin 14C4304 Am-Europharma

Corporation

1-Apr-14 Notified

14 04 01 2399 Vancomycin Hydrochloride Vancomet E926305 Carels

Pharmaceuticals Inc.

1-Apr-14 Notified

14 04 01 2400 Flucloxacillin Stafloxin 30625 Westmont

Pharmaceuticals,

Inc.

1-Apr-14 Notified

14 04 01 2401 Clarithromycin Clariwin CLRH0052 Brown & Burk

Philippines Inc.

1-Apr-14 Notified

14 04 01 2402 Ceftriaxone Sodium Forgram NY4E029 United Laboratories,

Inc.

1-Apr-14 Notified

14 04 01 2403 Ceftriaxone Sodium Forgram NY4E028 United Laboratories,

Inc.

1-Apr-14 Notified

14 04 01 2404 Meropenem Merozan 1400890 PharmAsia-Cuvest,

Inc.

1-Apr-14 Notified

14 04 01 2405 Cefepime (as hydrochloride) Zepim NA001 PharmAsia-Cuvest,

Inc.

1-Apr-14 Notified

14 04 01 2406 Ceftazidime (as pentahydrate) Tazidem 14001 PharmAsia-Cuvest,

Inc.

1-Apr-14 Notified

14 04 01 2407 Cefalexin Forexine GCU2-554 GX International,

Inc.

1-Apr-14 Notified

14 04 01 2408 Cefalexin (as monohydrate) Forexine GCF5B-011 GX International,

Inc.

1-Apr-14 Notified

14 04 01 2409 Amoxicillin (as trihydrate) AMX 410063 Wert Philippines,

Inc.

1-Apr-14 Notified

14 04 01 2410 Ceftriaxone Sodium Auroxone 1000 OTXID3090A

(sterile water-

IT543061)

Ambica Intenational

Trading Corporation

1-Apr-14 Notified

14 04 01 2411 Ceftriaxone Rocephin B0116B02 Roche Philippines,

Inc.

1-Apr-14 Notified

14 04 01 2412 Cefuroxime (as sodium) Mericef N-3522 BF Merren

Pharmaceuticals

1-Apr-14 Notified

14 04 01 2413 Mupirocin Bactroban 4BA18 GlaxoSmithKline

Philippines Inc.

1-Apr-14 Notified

14 04 01 2414 Co-Amoxiclav Augmentin 668926 GlaxoSmithKline

Philippines Inc.

1-Apr-14 Notified

14 04 01 2415 Cefalexin Cefalin A015840 Asian Antibiotics,

Inc.

1-Apr-14 Notified

14 04 01 2416 Erythromycin (as stearate) Tromxene 947020 Steinbach Products,

Inc.

1-Apr-14 Notified

14 04 01 2417 Erythromycin (as stearate) Tromxene 946006 Steinbach Products,

Inc.

1-Apr-14 Notified

14 04 01 2418 Ceftriaxone (as sodium) Torocef W509A001 Torrent Pharma

Philippines Inc.

1-Apr-14 Notified

14 04 01 2419 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol

Fixcom 4 14FXC4 05 Lloyd Laboratories,

Inc.

1-Apr-14 Notified

14 04 01 2420 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol

4WTB4 04 Lloyd Laboratories,

Inc.

1-Apr-14 Notified

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

Page 1 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 01 2421 Amoxicillin (as trihydrate) Benedex PCB123 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2422 Amoxicillin (as trihydrate) Benedex PCB121 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2423 Amoxicillin (as trihydrate) Benedex PCB122 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2424 Amoxicillin (as trihydrate) PCB326 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2425 Amoxicillin (as trihydrate) Betamox PCB322 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2426 Amoxicillin (as trihydrate) Betamox PCB324 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2427 Amoxicillin (as trihydrate) Betamox PCB323 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2428 Amoxicillin (as trihydrate) Axmel PCB319 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2429 Amoxicillin (as trihydrate) Axmel PCB320 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2430 Amoxicillin (as trihydrate) Axmel PCB321 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2431 Amoxicillin (as trihydrate) Axmel PCB316 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2432 Amoxicillin (as trihydrate) Axmel PCB317 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2433 Amoxicillin (as trihydrate) Axmel PCB315 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2434 Amoxicillin (as trihydrate) Axmel PCB318 New Myrex

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2435 Azithromycin Azimex-500 0214 Seahorse Industries,

Incorporated

2-Apr-14 Notified

14 04 01 2436 Cefuroxime (as axetil) Altacef 36130151 Glenmark

Philippines, Inc.

2-Apr-14 Notified

14 04 01 2437 Clarithromycin Maclar 01132661 Glenmark

Philippines, Inc.

2-Apr-14 Notified

14 04 01 2438 Mupirocin + Betamethasone (as

dipropionate)

Foskina B 01131736 Glenmark

Philippines, Inc.

2-Apr-14 Notified

14 04 01 2439 Mupirocin Foskina 01131703 Glenmark

Philippines, Inc.

2-Apr-14 Notified

14 04 01 2440 Cefuroxime (as axetil) Altacef 36130150 Glenmark

Philippines, Inc.

2-Apr-14 Notified

14 04 01 2441 Co-Amoxiclav Alclav 4150087 Alkem Laboratories,

Corp.

2-Apr-14 Notified

14 04 01 2442 Sultamicillin (as tosylate) Zunamyn 4B286A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2443 Amoxicillin (as trihydrate) 4B454A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2444 Cefalexin (as monohydrate) Medoxine 4C171A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

Page 2 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 01 2445 Sultamicillin (as tosylate) Silgram 4B099A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2446 Co-Amoxiclav Aviclav 4B453A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2447 Cloxacillin (as sodium) Clox 4B124A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2448 Co-Amoxiclav Natravox 14NS102 Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2449 Co-Amoxiclav Natravox 14NS207 Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2450 Cefaclor (as monohydrate) Xeclocef 4B332A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2451 Cefuroxime (as axetil) Zafex 4C157A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2452 Cefuroxime (as axetil) Zafex 3I172A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2453 Co-Amoxiclav Inoclav 4B417A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2454 Amoxicillin (as trihydrate) Medimoxil 76 / BAX2063 MG Prime

Pharmaceutical Inc.

2-Apr-14 Notified

14 04 01 2455 Cefalexin (as monohydrate) Cendalex 4C193A MG Prime

Pharmaceutical Inc.

2-Apr-14 Notified

14 04 01 2456 Cefuroxime (as axetil) Euroxime 4A122A Lloyd Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2457 Cloxacillin (as sodium) Oxaclen 17 / BCLX4017 MG Prime

Pharmaceutical Inc.

2-Apr-14 Notified

14 04 01 2458 Amoxicillin (as trihydrate) Medimoxil 73 / BAX4059 MG Prime

Pharmaceutical Inc.

2-Apr-14 Notified

14 04 01 2459 Amoxicillin (as trihydrate) Medimoxil 72 BAX5065 MG Prime

Pharmaceutical Inc.

2-Apr-14 Notified

14 04 01 2460 Nystatin Afunginal L0124009 Euro Generics

International Phils.,

Inc.

2-Apr-14 Notified

14 04 01 2461 Clindamycin Hydrochloride Dalamax 14DLM-1 Interphil

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2462 Rifampicin + Isoniazid Rimactazid 1401 Interphil

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2463 Cefalexin Ceporex 14CG-3 Interphil

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2464 Clindamycin Hydrochloride Dalamax 14DLM-2 Interphil

Laboratories, Inc.

2-Apr-14 Notified

14 04 01 2465 Cefuroxime (as axetil) Zegen ZCTC13027 United Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2466 Cefuroxime (as axetil) Zegen ZCTC13025 United Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2467 Cefuroxime (as axetil) Zegen ZCTC13026 United Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2468 Cefuroxime (as axetil) Zegen ZCTB13003 United Laboratories,

Inc.

2-Apr-14 Notified

14 04 01 2469 Cefuroxime (as axetil) Zegen ZCTB13004 United Laboratories,

Inc.

2-Apr-14 Notified

Page 3 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 01 2470 Amoxicillin (as trihydrate) Vhellox 500 B703 Pasteur

Pharmaceutical

Sales

2-Apr-14 Notified

14 04 01 2471 Ceftazidime (as pentahydrate) Flazidem A626 Pasteur

Pharmaceutical

Sales

2-Apr-14 Notified

14 04 01 2472 Co-Amoxiclav 4256076A RiteMed Phils Inc. 2-Apr-14 HOLD

14 04 01 2473 Cefuroxime Axetil UCTB13004 RiteMed Phils Inc. 2-Apr-14 HOLD

14 04 01 2474 Cefuroxime Lasuzef 31172 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2475 Cefuroxime Lasuzef 31173 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2476 Cefuroxime Lasuzef 31176 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2477 Cefuroxime Lasuzef 31178 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2478 Cefuroxime Lasuzef 31177 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2479 Cefuroxime Lasuzef 31181 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2480 Cefuroxime Lasuzef 31174 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2481 Cefuroxime Lasuzef 31174 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2482 Cefuroxime Lasuzef 31171 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2483 Cefuroxime Lasuzef 31180 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2484 Cefuroxime Lasuzef 31179 Sel-J

Pharmaceuticals and

Distributor

2-Apr-14 Notified

14 04 01 2485 Clindamycin (as hydrochloride) 43007 Scheele

Laboratories

Phils.,Inc.

2-Apr-14 Notified

14 04 02 2486 Azithromycin (as monohydrate) Azyth EC1490 Sandoz Philippines

Corp.

3-Apr-14 Notified

14 04 02 2487 Clarithromycin Claryl PE 401 Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

Page 4 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 02 2488 Azithromycin (as dihydrate) Zit-OD FE66B401 Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2489 Co-Amoxiclav Comxicla ET324004PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2490 Co-Amoxiclav Comxicla ET324005PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2491 Co-Amoxiclav Comxicla ET324006PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2492 Co-Amoxiclav Comxicla ET324007PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2493 Co-Amoxiclav Comxicla ET324008PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2494 Co-Amoxiclav Comxicla ET324009PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2495 Co-Amoxiclav Comxicla ET324010PH Suhitas

Pharmaceuticals Inc.

3-Apr-14 Notified

14 04 02 2496 Cefalexin Diacef 28062 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2497 Cefalexin Diacef 28058 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2498 Cefalexin Diacef 28059 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2499 Cefalexin Diacef 28060 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2500 Cefalexin Diacef 28061 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2501 Cefalexin Diacef 28063 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2502 Cefalexin (as monohydrate) Diacef 29060 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2503 Cefalexin (as monohydrate) Diacef 29061 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2504 Cefalexin (as monohydrate) Diacef 29056 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2505 Cefalexin (as monohydrate) Diacef 29059 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2506 Cefalexin (as monohydrate) Diacef 29055 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2507 Cefalexin (as monohydrate) Diacef 29057 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2508 Cefalexin (as monohydrate) Diacef 29058 Diamond

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2509 Ampicillin Sodium / Sulbactam Sodium Unasyn 13510805 Pfizer, Inc. 3-Apr-14 Notified

Page 5 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 02 2510 Lincomycin (as hydrochloride) Lincocin 429-58005 Pfizer, Inc. 3-Apr-14 Notified

14 04 02 2511 Lincomycin (as hydrochloride) Lincocin 429-58004 Pfizer, Inc. 3-Apr-14 Notified

14 04 02 2512 Cefuroxime Axetil Cimex F400058 Multicare

Pharmaceuticals

Phils.,Inc.

3-Apr-14 Notified

14 04 02 2513 Cefuroxime (as axetil) Cimex 403045 Multicare

Pharmaceuticals

Phils.,Inc.

3-Apr-14 Notified

14 04 02 2514 Cefuroxime Axetil Cimex 403030 Multicare

Pharmaceuticals

Phils.,Inc.

3-Apr-14 Notified

14 04 02 2515 Cefuroxime (as axetil) Cimex 403041 Multicare

Pharmaceuticals

Phils.,Inc.

3-Apr-14 Notified

14 04 02 2516 Cefuroxime (as axetil) Cimex 403046 Multicare

Pharmaceuticals

Phils.,Inc.

3-Apr-14 Notified

14 04 02 2517 Azithromycin (as dihydrate) Zithrocare 500 333P304X Khriz Pharma

Trading Inc.

3-Apr-14 Notified

14 04 02 2518 Cloxacillin Sodium Medaclox 403039 Sea Pharma Options

Inc.

3-Apr-14 Notified

14 04 02 2519 Clindamycin (as phosphate) Clindatec CLIA4A1 Triple Tact Import &

Export Corp.

3-Apr-14 Notified

14 04 02 2520 Fluocinolone acetonide, Polymexin B

sulfate, Neomycin sulfate

Aplosyn Otic

Solution

16DBA Pascual

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2521 Ampicillin Sodium Vatacil 1402768 Elin

Pharmaceuticals,

Inc.

3-Apr-14 Notified

14 04 02 2522 Ampicillin Sodium Vatacil 1402767 Elin

Pharmaceuticals,

Inc.

3-Apr-14 Notified

14 04 02 2523 Ampicillin Sodium Vatacil 1402769 Elin

Pharmaceuticals,

Inc.

3-Apr-14 Notified

14 04 02 2524 Cefalexin (as monohydrate) Exel PDB082 New Myrex

Laboratories, Inc.

3-Apr-14 Notified

14 04 02 2525 Cefuroxime (as sodium) Zefuxim 36M1311 Singapore

Pharmawealth

Lifesciences, Inc.

3-Apr-14 Notified

14 04 02 2526 Mupirocin Bactroban 4BC02 GlaxoSmithKline

Philippines Inc.

3-Apr-14 Notified

14 04 02 2527 Clindamycin (as hydrochloride) Clindal OPCC1-026 One Pharma

Co.,Inc.

3-Apr-14 Notified

14 04 02 2528 Clarithromycin Clarithro-

Natrapharm

32-1046-5D Natrapharm, Inc. 3-Apr-14 Notified

14 04 02 2529 Co-Amoxiclav Clavsin 4B423A Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2530 Cefaclor (as monohydrate) Verzat 4C169A Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2531 Co-Amoxiclav Natravox 14NS307 Lloyd Laboratories,

Inc.

3-Apr-14 Notified

Page 6 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 02 2532 Co-Amoxiclav Natravox 14NS101 Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2533 Co-Amoxiclav Natravox 14NS208 Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2534 Co-Amoxiclav Natravox 14NS209 Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2535 Cefuroxime (as axetil) Zoltax 14Z2 02 Lloyd Laboratories,

Inc.

3-Apr-14 Notified

14 04 02 2536 Vancomycin Hydrochloride B016913BA Hospira Philippines,

Inc.

3-Apr-14 Notified

14 04 02 2537 Cefuroxime Lasuzef 31191 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2538 Cefuroxime Lasuzef 31189 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2539 Cefuroxime Lasuzef 31192 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2540 Cefuroxime Lasuzef 31182 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2541 Cefuroxime Lasuzef 31188 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2542 Cefuroxime Lasuzef 31183 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2543 Cefuroxime Lasuzef 31195 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2544 Cefuroxime Lasuzef 31187 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2545 Cefuroxime Lasuzef 31190 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2546 Cefuroxime Lasuzef 31193 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2547 Cefuroxime Lasuzef 31194 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2548 Cefepime Cepidime 31186 Sel-J

Pharmaceuticals and

Distributor

3-Apr-14 Notified

14 04 02 2549 Cefalexin (as monohydrate) Madexin 402003 Medic Aid

Distributors, Inc.

3-Apr-14 Notified

14 04 02 2550 Cefalexin Madexin 402063 Medic Aid

Distributors, Inc.

3-Apr-14 Notified

Page 7 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 02 2551 Cefalexin Madexin 402062 Medic Aid

Distributors, Inc.

3-Apr-14 Notified

14 04 02 2552 Cefalexin (as monohydrate) Madexin 403002 Medic Aid

Distributors, Inc.

3-Apr-14 Notified

14 04 02 2553 Clarithromycin Clariget 106F01 Getz Pharma Phils.,

Inc.

3-Apr-14 Notified

14 04 02 2554 Clarithromycin Clariget 110F01 Getz Pharma Phils.,

Inc.

3-Apr-14 Notified

14 04 02 2555 Clarithromycin Clariget 314D01 Getz Pharma Phils.,

Inc.

3-Apr-14 Notified

14 04 02 2556 Ampicillin Sodium / Sulbactam Sodium Silgram 1165 YSS Laboratories

Co.,Inc.

3-Apr-14 Notified

14 04 02 2557 Ampicillin Sodium / Sulbactam Sodium Silgram 1164 YSS Laboratories

Co.,Inc.

3-Apr-14 Notified

14 04 02 2558 Ampicillin Sodium / Sulbactam Sodium Silgram 1163 YSS Laboratories

Co.,Inc.

3-Apr-14 Notified

14 04 02 2559 Clarithromycin Maxulid EMM401 Verheilen

Pharmaceuticals,

Inc.

3-Apr-14 Notified

14 04 03 2560 Cloxacillin (as sodium) 43021 Scheele

Laboratories

Phils.,Inc.

4-Apr-14 Notified

14 04 03 2561 Cloxacillin (as sodium) 43020 Scheele

Laboratories

Phils.,Inc.

4-Apr-14 Notified

14 04 03 2562 Cloxacillin (as sodium) 43019 Scheele

Laboratories

Phils.,Inc.

4-Apr-14 Notified

14 04 03 2563 Flucloxacillin (as sodium) Coxafen 4B216A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2564 Amoxicillin Penbiosyn D261601 Medi-RX, Inc. 4-Apr-14 Notified

14 04 03 2565 Co-Amoxiclav Addex E1134306 Carels

Pharmaceuticals Inc.

4-Apr-14 Notified

14 04 03 2566 Cefalexin (as monohydrate) Diacef 29063 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2567 Cefalexin (as monohydrate) Diacef 29064 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2568 Cefalexin (as monohydrate) Diacef 29065 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2569 Cefalexin (as monohydrate) Diacef 29066 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2570 Cefalexin (as monohydrate) Diacef 29067 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2571 Cefalexin (as monohydrate) Diacef 29068 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2572 Chloramphenicol (as palmitate) Zerruchlor 18944 N Pharmatechnica

Laboratory, Inc.

4-Apr-14 Notified

14 04 03 2573 Cefalexin Forexine GCU2-555 GX International,

Inc.

4-Apr-14 Notified

Page 8 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 03 2574 Dexamethasone Sodium Phosphate /

Neomycin Base / Polymyxin B Sulfate Otic

Solution

Syntemax 4D115 Optaderm Pharma

Inc.

4-Apr-14 Notified

14 04 03 2575 Cefalexin (as monohydrate) Diacef 29062 Diamond

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2576 Cefalexin (as monohydrate) Exel PDB083 New Myrex

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2577 Doxycycline Hydrochloride 4B492 Drugmaker's

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2578 Cefaclor (as monohydrate) Eliclor 4B509 Drugmaker's

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2579 Cloxacillin (as sodium) 4B163 Drugmaker's

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2580 Clarithromycin 4B503 Drugmaker's

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2581 Clarithromycin Klaryz 4B500 Drugmaker's

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2582 Clarithromycin Klaryz 4B501 Terramedic, Inc. 4-Apr-14 Notified

14 04 03 2583 Doxycycline Hyclate 43994 Scheele

Laboratories

Phils.,Inc.

4-Apr-14 Notified

14 04 03 2584 Cefalexin Ceporex 14CID-2 Interphil

Laboratories, Inc.

4-Apr-14 Notified

14 04 03 2585 Co-Amoxiclav Alclav 4150060 Alkem Laboratories,

Corp.

4-Apr-14 Notified

14 04 03 2586 Cefuroxime (as sodium) Hiquacef B486E Pasteur

Pharmaceutical

Sales

4-Apr-14 Notified

14 04 03 2587 Amoxicillin (as trihydrate) Amelox 14D130 Square

Pharmaceuticals,

Inc.

4-Apr-14 Notified

14 04 03 2588 Cefuroxime (as axetil) Sqcef 14C128 Square

Pharmaceuticals,

Inc.

4-Apr-14 Notified

14 04 03 2589 Cefalexin (as monohydrate) Canelin 14D131 Square

Pharmaceuticals,

Inc.

4-Apr-14 Notified

14 04 03 2590 Cefuroxime (as axetil) Sqcef 14D129 Square

Pharmaceuticals,

Inc.

4-Apr-14 Notified

14 04 03 2591 Ampicillin (as sodium) + Sulbactam (as

sodium)

Unasyn RTU 1339G017R Pfizer, Inc. 4-Apr-14 Notified

14 04 03 2592 Co-Amoxiclav Enhamox 4C170A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2593 Co-Amoxiclav Megaclav 4B082A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2594 Co-Amoxiclav Solclav 4B445A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2595 Cefaclor (as monohydrate) Rimaclor 4C199A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

Page 9 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 03 2596 Cefaclor (as monohydrate) Verzat 4C302A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2597 Cefalexin (as monohydrate) Bandax 4C249A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2598 Co-Amoxiclav Clovimax 4B482A Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2599 Clindamycin (as hydrochloride) EC1728 Sandoz Philippines

Corp.

4-Apr-14 Notified

14 04 03 2600 Neomycin + Gramicidin + Nystatin +

Triamcinolone Acetonide

Oticom 4F101 Medilife Pharma,

Inc.

4-Apr-14 Notified

14 04 03 2601 Co-Amoxiclav Natravox 14NT301 Lloyd Laboratories,

Inc.

4-Apr-14 Notified

14 04 03 2602 Cefepime (as hydrochloride) Cepiram A13102SP The Cathay Drug

Co., Inc.

4-Apr-14 Notified

14 04 03 2603 Cefepime (as hydrochloride) Cepiram A14009SP The Cathay Drug

Co., Inc.

4-Apr-14 Notified

14 04 03 2604 Cefepime (as hydrocholoride) Cepiram A14008SP The Cathay Drug

Co., Inc.

4-Apr-14 Notified

14 04 03 2605 Cefepime (as hydrochloride) Cepiram A14007SP The Cathay Drug

Co., Inc.

4-Apr-14 Notified

14 04 08 2606 Cefalexin (as monohydrate) 150322 Pascual

Laboratories, Inc.

8-Apr-14 Notified

14 04 08 2607 Co-Amoxiclav Sovlan SYT5 G006 Yung Shin

(Philippines), Inc.

8-Apr-14 Notified

14 04 08 2608 Clindamycin (as phosphate) Tidact TDI G001 Yung Shin

(Philippines), Inc.

8-Apr-14 Notified

14 04 08 2609 Cefaclor Xelent A016011 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2610 Cefalexin Cefalin A015990 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2611 Cefalexin Cefalin A015988 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2612 Cefalexin Cefalin A015989 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2613 Cefalexin A015957 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2614 Cefalexin A015986 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2615 Cefalexin A015986 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2616 Amoxicillin Himox A015983 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2617 Cefaclor A015834 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2618 Cefalexin Cefalin A015962 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2619 Amoxicillin Himox A015949 Asian Antibiotics,

Inc.

8-Apr-14 Notified

Page 10 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 08 2620 Phenoxymethylpenicillin Potassium Sumapen A015948 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2621 Cefixime Tergecef A014730 Asian Antibiotics,

Inc.

8-Apr-14 Notified

14 04 08 2622 Cefuroxime Axetil Axet ATFB0011 Xeno

Pharmaceuticals

Phils Inc.

8-Apr-14 Notified

14 04 08 2623 Cefuroxime Axetil Axet ATFB0012 Xeno

Pharmaceuticals

Phils Inc.

8-Apr-14 Notified

14 04 08 2624 Cefuroxime Sodium Cefucil DSAM13576 I.E. Medica, Inc. 8-Apr-14 Notified

14 04 08 2625 Co-Amoxiclav Amoclav AUAI-401 United Laboratories,

Inc.

8-Apr-14 Notified

14 04 08 2626 Co-Amoxiclav Amoclav AUAM-401 United Laboratories,

Inc.

8-Apr-14 Notified

14 04 08 2627 Co-Amoxiclav Lox QE003 Unimex, Inc. 8-Apr-14 Notified

14 04 08 2628 Co-Amoxiclav Duoclav B311 Pasteur

Pharmaceutical

Sales

8-Apr-14 Notified

14 04 08 2629 Co-Amoxiclav Duoclav B312 Pasteur

Pharmaceutical

Sales

8-Apr-14 Notified

14 04 08 2630 Erythromycin 4F125 Celsus

Pharmaceuticals

Philippines, Inc.

8-Apr-14 Notified

14 04 08 2631 Cefalexin (as monohydrate) Forexine GCF5B-014 GX International,

Inc.

8-Apr-14 Notified

14 04 08 2632 Cefalexin Forexine GCU2-556 GX International,

Inc.

8-Apr-14 Notified

14 04 08 2633 Prednisolone Acetate / Neomycin Sulfate /

Polymyxin B Sulfate

Predmycin-P E71695 Zuellig Pharma

Corporation

8-Apr-14 Notified

14 04 08 2634 Prednisolone Acetate / Neomycin Sulfate /

Polymyxin B Sulfate

Predmycin-P E71695 Zuellig Pharma

Corporation

8-Apr-14 Notified

14 04 08 2635 Clindamycin (as phosphate) + Benzoyl

Peroxide

Duac 075R GlaxoSmithKline

Philippines Inc.

8-Apr-14 Notified

14 04 08 2636 Clindamycin (as phosphate) + Benzoyl

Peroxide

Duac 075R GlaxoSmithKline

Philippines Inc.

8-Apr-14 Notified

14 04 08 2637 Clindamycin (as phosphate) + Benzoyl

Peroxide

Duac 789Q GlaxoSmithKline

Philippines Inc.

8-Apr-14 Notified

14 04 08 2638 Co-Amoxiclav Augmentin 661485 GlaxoSmithKline

Philippines Inc.

8-Apr-14 Notified

14 04 08 2639 Meropenem Trihydrate Meronem KR057 (Lot

No.on crimp:

2B131I10)

AstraZeneca

Pharmaceuticals

(Phils.), Inc.

8-Apr-14 Notified

14 04 08 2640 Meropenem Trihydrate Meronem KP726 (Lot

No.on crimp:

1A13F04)

AstraZeneca

Pharmaceuticals

(Phils.), Inc.

8-Apr-14 Notified

14 04 08 2641 Meropenem Trihydrate Meronem KP980 (Lot

No.on crimp:

1A13F04)

AstraZeneca

Pharmaceuticals

(Phils.), Inc.

8-Apr-14 Notified

Page 11 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 08 2642 Cefalexin (as monohydrate) Xeface 14AXE01 Ace

Pharmaceuticals,

Inc.

8-Apr-14 Notified

14 04 08 2643 Cloxacillin Sodium Cloxapen BC-35002 Steinbach Products,

Inc.

8-Apr-14 Notified

14 04 08 2644 Polymyxin B Sulfate / Neomycin (as

sulfate) / Dexamethasone (as sodium

phosphate)

Maxoptic 4F129 Vendiz

Pharmaceuticals Inc.

8-Apr-14 Notified

14 04 08 2645 Polymyxin B Sulfate / Neomycin (as

sulfate) / Hydrocortisone (as acetate)

Hydrospor 4F127 Vendiz

Pharmaceuticals Inc.

8-Apr-14 Notified

14 04 08 2646 Amoxicillin (as trihydrate) Betamox PDB098 New Myrex

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2647 Amoxicillin (as trihydrate) Betamox PDB099 New Myrex

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2648 Cefalexin (as monohydrate) Cepham PDB094 New Myrex

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2649 Cefalexin (as monohydrate) Cepham PDB093 New Myrex

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2650 Cefalexin (as monohydrate) Exel PDB084 New Myrex

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2651 Azithromycin (as dihydrate) Thromaxin P0124002 Euro Generics

International Phils.,

Inc.

10-Apr-14 Notified

14 04 08 2652 Nystatin Stanys L0124010 Euro Generics

International Phils.,

Inc.

10-Apr-14 Notified

14 04 08 2653 Cefaclor (as monohydrate) 4B427 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2654 Doxycycline HCl Pidclin 4B493 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2655 Cefalexin 4C119 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2656 Clarithromycin 4C168 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2657 Amoxicillin Teramoxyl 4C123 Terramedic, Inc. 10-Apr-14 Notified

14 04 08 2658 Clarithromycin Klaryz 4B456 Terramedic, Inc. 10-Apr-14 Notified

14 04 08 2659 Cefalexin (as monohydrate) Xinflex 4C112 Terramedic, Inc. 10-Apr-14 Notified

14 04 08 2660 Cefalexin (as monohydrate) Xinflex 4C130 Terramedic, Inc. 10-Apr-14 Notified

14 04 08 2661 Co-Amoxiclav Vamox 4B506 Terramedic, Inc. 10-Apr-14 Notified

14 04 08 2662 Clarithromycin 4C166 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2663 Clarithromycin 4C167 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2664 Clarithromycin 4C110 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2665 Clarithromycin 4B504 Drugmaker's

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2666 Chloramphenicol 4C223 Drugmaker's

Laboratories, Inc.

10-Apr-14 HOLD

Page 12 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 08 2667 Erythromycin Ilosone 14ILE-2 Interphil

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2668 Cefalexin Ceporex 14CG-4 Interphil

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2669 Amoxicillin (as trihydrate) Spectra A4142 APT Drug Trrading 10-Apr-14 Notified

14 04 08 2670 Cefalexin (as monohydrate) Tonnaxe A4122 APT Drug Trrading 10-Apr-14 Notified

14 04 08 2671 Cloxacillin (as sodium) Cloxacin L4272 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2672 Cefuroxime (as axetil) Cefucure AO41130 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2673 Cefaclor (as monohydrate) Clormed AH41121 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2674 Cefaclor (as monohydrate) Linnoxzil BN41121 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2675 Cefuroxime (as axetil) Xyfrox H4491 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2676 Cefuroxime (as axetil) Xyfrox H4591 J.M. Tolmann

Laboratories, Inc.

10-Apr-14 Notified

14 04 08 2677 Cloxacillin (as sodium) 43047 Scheele

Laboratories

Phils.,Inc.

10-Apr-14 Notified

14 04 08 2678 Cloxacillin Sodium 43048 Scheele

Laboratories

Phils.,Inc.

10-Apr-14 Notified

14 04 08 2679 Cloxacillin (as sodium) 43022 Scheele

Laboratories

Phils.,Inc.

10-Apr-14 Notified

14 04 08 2680 Amoxicillin (as trihydrate) Medimoxil BAX2064 / 77 MG Prime

Pharmaceutical Inc.

10-Apr-14 Notified

14 04 08 2681 Cloxacillin (as sodium) Oxaclen BCLX2067 / 66 MG Prime

Pharmaceutical Inc.

10-Apr-14 Notified

14 04 08 2682 Cloxacillin (as sodium) Oxaclen BCLX3029 / 30 MG Prime

Pharmaceutical Inc.

10-Apr-14 Notified

14 04 08 2683 Cefuroxime (as axetil) Eurimax 403035 Scheeling Pharma

Care Link Inc.

10-Apr-14 Notified

14 04 08 2684 Co-Amoxiclav Bioclavid EB6411 Sandoz Philippines

Corp.

10-Apr-14 Notified

14 04 08 2685 Gentamicin Servigenta 10977610 Sandoz Philippines

Corp.

10-Apr-14 Notified

14 04 08 2686 Co-Amoxiclav Bioclavid EB6409 Sandoz Philippines

Corp.

10-Apr-14 Notified

14 04 08 2687 Amoxicillin Varolox R1408 Novagen

Pharmaceutical Co.,

Inc.

10-Apr-14 Notified

14 04 08 2688 Amoxicillin Varolox R1405 Novagen

Pharmaceutical Co.,

Inc.

10-Apr-14 Notified

Page 13 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 08 2689 Amoxicillin Varolox R1403 Novagen

Pharmaceutical Co.,

Inc.

10-Apr-14 Notified

14 04 08 2690 Clarithromycin Clarithro-

Natrapharm

39176XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2691 Clarithromycin Clarithro-

Natrapharm

35885XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2692 Clarithromycin Clarithro-

Natrapharm

39173XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2693 Clarithromycin Clarithro-

Natrapharm

39172XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2694 Clarithromycin Clarithro-

Natrapharm

39175XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2695 Clarithromycin Clarithro-

Natrapharm

39177XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2696 Clarithromycin Clarithro-

Natrapharm

39178XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2697 Clarithromycin Clarithro-

Natrapharm

39174XP Natrapharm, Inc. 10-Apr-14 Notified

14 04 08 2698 Co-Amoxiclav Natravox 14NS208 Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2699 Doxycycline (as hyclate) Doxylin 4B304A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2700 Cefuroxime (as axetil) Zafex 3I172A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2701 Co-Amoxiclav Comox 4B250A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2702 Co-Amoxiclav Clovimed 4C046A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2703 Co-Amoxiclav Natravox 14NS102 Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2704 Co-Amoxiclav Natravox 14NS210 Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2705 Co-Amoxiclav Lactamox 4C040A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2706 Co-Amoxiclav Claxic 4C156A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2707 Cefradine (as monohydrate) Zepdril 4C158A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2708 Co-Amoxiclav Natravox 14NS307 Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2709 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol

Fixcom 4 14FXC4 06 Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2710 Amoxicillin (as trihydrate) Broadmetz 4A577A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2711 Cefuroxime (as axetil) Zafex 3K040A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2712 Cefalexin (as monohydrate) Falex 4C050A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2713 Sultamicillin (as tosylate) Tosylam 4B057A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

Page 14 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 08 2714 Cefuroxime (as axetil) Pediacef 4B228A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 08 2715 Co-Amoxiclav Pediaclav 4B225A Lloyd Laboratories,

Inc.

10-Apr-14 Notified

14 04 10 2716 Amoxicillin (as trihydrate) Bioxill 18940 IH Peniel

Pharmaceutical

11-Apr-14 Notified

14 04 10 2717 Amoxicillin (as trihydrate) Bioxill 18941 IH Peniel

Pharmaceutical

11-Apr-14 Notified

14 04 10 2718 Clindamycin (as phosphate) Clindal 4001 One Pharma

Co.,Inc.

11-Apr-14 Notified

14 04 10 2719 Amoxicillin (as trihydrate) Zerrsox 18938 N Pharmatechnica

Laboratory, Inc.

11-Apr-14 Notified

14 04 10 2720 Cefalexin (as monohydrate) Flaximed 4B183 CHMI Pharma, Inc. 11-Apr-14 Notified

14 04 10 2721 Amoxicillin (as trihydrate) Amorex 4B464 Drugmaker's

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2722 Sodium Fusidate Fucidin EJ3892 Zuellig Pharma

Corporation

11-Apr-14 Notified

14 04 10 2723 Rifampicin + Isoniazid + Pyridoxine

Hydrochloride + Pyrazinamide

HRZ Pedia Kit L014187 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2724 Rifampicin + Isoniazid + Pyridoxine

Hydrochloride + Pyrazinamide

HRZ Pedia Kit L014188 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2725 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083837 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2726 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083836 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2727 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083835 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2728 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083834 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2729 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083833 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2730 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083832 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2731 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083831 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2732 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083830 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2733 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol HCl

Quadtab M083829 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2734 Bacitracin + Polymyxin B + Neomycin Trimycin M4328 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2735 Rifampicin + Isoniazid Bifix M083486 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2736 Clindamycin HCl M083999 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2737 Clarithromycin Klaz M083805 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2738 Clarithromycin Klaz M083804 Amherst

Laboratories, Inc.

11-Apr-14 Notified

Page 15 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 10 2739 Clarithromycin Klaz M083801 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2740 Clarithromycin Klaz M083800 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2741 Clarithromycin Klaz M083799 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2742 Clarithromycin Klaz M083798 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2743 Clarithromycin Klaz M083797 Amherst

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2744 Cefaclor (as monohydrate) Ceflor 147003 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2745 Cefaclor Ceflor 125005 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2746 Cefaclor Ceflor 126006 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2747 Cefalexin (as monohydrate) Diacef 29072 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2748 Cefalexin (as monohydrate) Diacef 29071 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2749 Cefalexin (as monohydrate) Diacef 29070 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2750 Cefalexin Diacef 27036 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2751 Cefalexin Diacef 27037 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2752 Cefalexin Diacef 27038 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2753 Cefalexin (as monohydrate) Diacef 29069 Diamond

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2754 Cefalexin (as monohydrate) Cepham PDB096 New Myrex

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2755 Cefalexin (as monohydrate) Cepham PDB095 New Myrex

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2756 Amoxicillin (as trihydrate) Axmel PDB171 New Myrex

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2757 Amoxicillin (as trihydrate) Axmel PDB170 New Myrex

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2758 Amoxicillin (as trihydrate) Axmel PDB001 New Myrex

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2759 Cefalexin Ceporex 14CG-5 Interphil

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2760 Clindamycin HCl Dalacin C 14DCPR1 Interphil

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2761 Rifampicin + Isoniazid + Ethambutol HCl Tres 1401 Interphil

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2762 Cefuroxime (as sodium) Zefuxim 38M1301 Singapore

Pharmawealth

Lifesciences, Inc.

11-Apr-14 Notified

Page 16 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 10 2763 Cefotaxime (as sodium) Cefotax 66M1301 Singapore

Pharmawealth

Lifesciences, Inc.

11-Apr-14 Notified

14 04 10 2764 Clarithromycin Clarbact FUT4001 Blue Global (FZE) 11-Apr-14 Notified

14 04 10 2765 Clarithromycin Clarbact 4001 Blue Global (FZE) 11-Apr-14 Notified

14 04 10 2766 Chloramphenicol 9536 JB Orchid

Pharmaceuticals,

Inc.

11-Apr-14 Notified

14 04 10 2767 Amoxicillin (as trihydrate) Telsimox P131015 AD-Drugstel

Pharmaceutical

Laboratories, Inc.

11-Apr-14 Notified

14 04 10 2768 Cloxacillin (as sodium) 43049 Scheele

Laboratories

Phils.,Inc.

11-Apr-14 Notified

14 04 10 2769 Cloxacillin (as sodium) 43052 Scheele

Laboratories

Phils.,Inc.

11-Apr-14 Notified

14 04 10 2770 Cloxacillin (as sodium) 43050 Scheele

Laboratories

Phils.,Inc.

11-Apr-14 Notified

14 04 10 2771 Cefaclor (as monohydrate) 43014 Scheele

Laboratories

Phils.,Inc.

11-Apr-14 Notified

14 04 10 2772 Rifampicin / Ethambutol HCl / Isoniazid Myrin 144C006 Pfizer, Inc. 11-Apr-14 Notified

14 04 10 2773 Rifampicin / Ethambutol HCl / Isoniazid Myrin 144C005 Pfizer, Inc. 11-Apr-14 Notified

14 04 10 2774 Rifampicin / Ethambutol HCl / Isoniazid Myrin 144C004 Pfizer, Inc. 11-Apr-14 Notified

14 04 10 2775 Rifampicin / Ethambutol HCl / Isoniazid Myrin 144C003 Pfizer, Inc. 11-Apr-14 Notified

14 04 10 2776 Sultamicillin tosylate Unasyn 1439603A Pfizer, Inc. 11-Apr-14 Notified

14 04 10 2777 Sultamicillin (as tosylate) Tosylam 4B253A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2778 Clarithromycin Acroxyn 4B119A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2779 Co-Amoxiclav Altoclav 4A482A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2780 Co-Amoxiclav Altovox 4B422A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2781 Co-Amoxiclav Clavic 4A194A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2782 Co-Amoxiclav Clavic 4C049A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2783 Cefuroxime (as axetil) Rovix 4A306A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2784 Cefalexin (as monohydrate) Selzef 4B214A Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2785 Co-Amoxiclav Natravox 14NS212 Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2786 Co-Amoxiclav Natravox 14NS214 Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2787 Co-Amoxiclav Natravox 14NS211 Lloyd Laboratories,

Inc.

11-Apr-14 Notified

Page 17 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 10 2788 Co-Amoxiclav Natravox 14NS213 Lloyd Laboratories,

Inc.

11-Apr-14 Notified

14 04 10 2789 Meropenem Trihydrate Meromax 9073 YSS Laboratories

Co.,Inc.

11-Apr-14 Notified

14 04 10 2790 Meropenem Trihydrate Meromax 9071 YSS Laboratories

Co.,Inc.

11-Apr-14 Notified

14 04 10 2791 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8127C YSS Laboratories

Co.,Inc.

11-Apr-14 Notified

14 04 10 2792 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8128C YSS Laboratories

Co.,Inc.

11-Apr-14 Notified

14 04 10 2793 Meropenem Trihydrate Meromax 9074 YSS Laboratories

Co.,Inc.

11-Apr-14 Notified

14 04 15 2794 Amoxicillin Penbiosyn I111401 Medi-RX, Inc. 14-Apr-14 HOLD

14 04 15 2795 Amilacin Amikacide P010346 Amherst

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2796 Amilacin Amikacide P010347 Amherst

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2797 Doxycycline Hyclate Dyna-

Doxycycline

D6690 Crisdy-Na

Corporation

14-Apr-14 Notified

14 04 15 2798 Clarithromycin Klaricid 39179XP Abbott Laboratories

(Philippines)

14-Apr-14 Notified

14 04 15 2799 Clarithromycin Klaricid 39180XP Abbott Laboratories

(Philippines)

14-Apr-14 Notified

14 04 15 2800 Clarithromycin Klaricid 39181XP Abbott Laboratories

(Philippines)

14-Apr-14 Notified

14 04 15 2801 Cefalexin Diacef 27039 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2802 Cefalexin Diacef 27040 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2803 Cefalexin Diacef 27041 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2804 Amoxicillin (as trihydrate) Moxylor B07034 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2805 Amoxicillin (as trihydrate) Moxylor B07033 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2806 Amoxicillin (as trihydrate) Moxylor B07032 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2807 Cefalexin (as monohydrate) Diacef 29073 Diamond

Laboratories, Inc.

14-Apr-14 Notified

14 04 15 2808 Co-Amoxiclav Addex E1576402 Carels

Pharmaceuticals Inc.

14-Apr-14 Notified

14 04 15 2809 Cefuroxime Sodium Cefucil SCC3001 I.E. Medica, Inc. 14-Apr-14 Notified

14 04 15 2810 Clarithromycin Klaryth CCKU1-021 The Cathay YSS

Distributors Co., Inc.

14-Apr-14 Notified

14 04 15 2811 Clarithromycin Klaryth CCKU1-022 The Cathay YSS

Distributors Co., Inc.

14-Apr-14 Notified

Page 18 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 15 2812 Cefuroxime (as sodium) Profurex P142021A The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2813 Cefixime Triocef 141129 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2814 Streptomycin Sulfate P142019 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2815 Streptomycin Sulfate P142017 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2816 Streptomycin Sulfate P141006 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2817 Streptomycin Sulfate P142014 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2818 Streptomycin Sulfate P142015 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2819 Streptomycin Sulfate P142016 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2820 Streptomycin Sulfate P141005 The Cathay Drug

Co., Inc.

14-Apr-14 Notified

14 04 15 2821 Amoxicillin (as trihydrate) Globapen GXD1-122 GX International,

Inc.

14-Apr-14 Notified

14 04 15 2822 Amoxicillin (as trihydrate) Globapen GXU7-104 GX International,

Inc.

14-Apr-14 Notified

14 04 15 2823 Cefuroxime (as axetil) Zinnat C668266 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2824 Co-Amoxiclav Augmentin ES 979 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2825 Mupirocin Bactroban 4BC03 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2826 Amoxicillin (as trihydrate) Amoxil 471 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2827 Co-Amoxiclav Augmentin 664425 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2828 Co-Amoxiclav Augmentin DS 346 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2829 Mupirocin Bactroban 4BC04 GlaxoSmithKline

Philippines Inc.

14-Apr-14 Notified

14 04 15 2830 Amoxicillin (as trihydrate) 4343 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2831 Cefalexin (as monohydrate) Cefatrene AD4122 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2832 Cefalexin (as monohydrate) Mefolex C4124 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2833 Cefuroxime (as axetil) Biroxil AS44130 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2834 Cloxacillin (as sodium) Cloxipen BK4372 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2835 Cefuroxime (as axetil) Xyfrox BK42131 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

Page 19 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 15 2836 Cefuroxime (as axetil) Biroxil AS45131 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2837 Cefuroxime (as axetil) Biroxil AS43130 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2838 Cefuroxime (as axetil) Biroxil AS46131 J.M. Tolmann

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2839 Chloramphenicol (as palmitate) Zinett 0614021 Lumar

Pharmaceutical

Laboratory

16-Apr-14 Notified

14 04 15 2840 Cefalexin (as monohydrate) Voxxim PDB168 Roddensers

Pharmaceuticals

16-Apr-14 Notified

14 04 15 2841 Cefalexin (as monohydrate) Cepham PDB097 New Myrex

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2842 Amoxicillin (as trihydrate) Axmel PDB172 New Myrex

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2843 Amoxicillin (as trihydrate) Axmel PDB002 New Myrex

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2844 Cloxacillin (as sodium) Lewinex PDB003 Lewison

Pharmaceuticals

Corporation

16-Apr-14 Notified

14 04 15 2845 Cefuroxime (as sodium) Clovixime 35099 GBF Pharma and

Medical Supplies

16-Apr-14 Notified

14 04 15 2846 Cefazolin (as sodium) Cloviz 35100 GBF Pharma and

Medical Supplies

16-Apr-14 Notified

14 04 15 2847 Ampicillin (as sodium) Clovillin 35117 GBF Pharma and

Medical Supplies

16-Apr-14 Notified

14 04 15 2848 Ampicillin (as sodium) Clovillin 35272 GBF Pharma and

Medical Supplies

16-Apr-14 Notified

14 04 15 2849 Chloramphenicol Typhechlor 4C209 Drugmaker's

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2850 Cloxacillin (as sodium) Cloxid 4B162 Drugmaker's

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2851 Cefradine 4C243 Drugmaker's

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2852 Cloxacillin (as sodium) Cloxid 4B140 Drugmaker's

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2853 Co-Amoxiclav Moxiking QE001 Unimex, Inc. 16-Apr-14 Notified

14 04 15 2854 Azithromycin (as dihydrate) Zithrobbas 2212 Raquel-Abbas

Pharmaceuticals &

Gen. Mdse.

16-Apr-14 Notified

14 04 15 2855 Nystatin Nystrin 2441 Raquel-Abbas

Pharmaceuticals &

Gen. Mdse.

16-Apr-14 Notified

14 04 15 2856 Erythromycin Ilosone DS 14IDS-5 Interphil

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2857 Erythromycin Ilosone 14ILE-3 Interphil

Laboratories, Inc.

16-Apr-14 Notified

14 04 15 2858 Clarithromycin Clariget OD 106F42 Getz Pharma Phils.,

Inc.

16-Apr-14 Notified

14 04 15 2859 Clarithromycin Clariget 331D01 Getz Pharma Phils.,

Inc.

16-Apr-14 Notified

Page 20 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 15 2860 Clarithromycin Clariget 110F01 Getz Pharma Phils.,

Inc.

16-Apr-14 Notified

14 04 15 2861 Clarithromycin Clariget 1004D02 Getz Pharma Phils.,

Inc.

16-Apr-14 Notified

14 04 15 2862 Cefuroxime (as axetil) Zurenix B782 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2863 Erythromycin (as stearate) Thromax 3603006 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2864 Cefuroxime (as sodium) Zurenix WFI B486D Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2865 Amoxicillin (as trihydrate) Vhellox 500 B654 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2866 Amoxicillin (as trihydrate) Vhellox 500 B655 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2867 Clarithromycin Clistanex Forte B618 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2868 Clarithromycin Clistanex Forte B617 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2869 Clarithromycin Clistanex Forte B619 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2870 Clarithromycin Clistanex Forte B620 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2871 Cefuroxime (as axetil) Zurenix B701 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2872 Cefuroxime (as axetil) Zurenix B702 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2873 Cefuroxime (as axetil) Zurenix B778 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2874 Cefuroxime (as axetil) Zurenix B779 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2875 Cefuroxime (as axetil) Zurenix B780 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2876 Cefuroxime (as axetil) Zurenix B781 Pasteur

Pharmaceutical

Sales

16-Apr-14 Notified

14 04 15 2877 Amoxicillin (as trihydrate) Brumox-500 BC0513016 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

Page 21 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 15 2878 Amoxicillin (as trihydrate) Brumox-500 BC0513019 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2879 Amoxicillin (as trihydrate) Brumox-500 BC0513015 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2880 Amoxicillin (as trihydrate) Brumox-500 BC0513018 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2881 Amoxicillin (as trihydrate) Brumox-500 BC0513014 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2882 Amoxicillin (as trihydrate) Brumox-500 BC0513011 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2883 Amoxicillin (as trihydrate) Brumox-500 BC0513008 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2884 Amoxicillin (as trihydrate) Brumox-500 BC0513009 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2885 Amoxicillin (as trihydrate) Brumox-500 BC0513017 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2886 Amoxicillin (as trihydrate) Brumox-500 BC0513007 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2887 Amoxicillin (as trihydrate) Brumox-500 BC0513012 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2888 Amoxicillin (as trihydrate) Brumox-500 BC0513006 Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2889 Meropenem (as trihydrate) 618E001 Hospira Philippines,

Inc.

16-Apr-14 Notified

14 04 15 2890 Co-Amoxiclav Koact 625 NX5014001-B Ambica Intenational

Trading Corporation

16-Apr-14 HOLD

14 04 15 2891 Cefuroxime (as axetil) Rucef 4A576A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2892 Cefaclor (as monohydrate) Vinsef 4C241A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2893 Co-Amoxiclav Clovimed 4C045A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2894 Cefuroxime (as axetil) Zegecef 4C255A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2895 Cefalexin (as monohydrate) Cendalex 4C191A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2896 Cefuroxime (as axetil) Rucef 4C235A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2897 Lincomycin Hydrochloride Adlynx 4B251A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2898 Cefuroxime (as axetil) Medzyme 4C225A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2899 Cloxacillin (as sodium) Solaze 4B341A Lloyd Laboratories,

Inc.

16-Apr-14 Notified

14 04 15 2900 Clindamycin (as phosphate) Dalaclin 3900018 International Apex

Pharmaceuticals,

Inc.

16-Apr-14 Notified

14 04 15 2901 Chloramphenicol (as sodium succinate) Klornik SX-14007 International Apex

Pharmaceuticals,

Inc.

16-Apr-14 Notified

Page 22 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 15 2902 Meropenem (as trihydrate) Meropen XB-14013 International Apex

Pharmaceuticals,

Inc.

16-Apr-14 Notified

14 04 15 2903 Piperacillin Sodium + Tazobactam Sodium Tazobak XB-13172 International Apex

Pharmaceuticals,

Inc.

16-Apr-14 Notified

14 04 15 2904 Sodium Fusidate Woncare BE03096 Hovid Inc. 16-Apr-14 Notified

14 04 15 2905 Sodium Fusidate Woncare BE03097 Hovid Inc. 16-Apr-14 Notified

14 04 15 2906 Doxycycline Hyclate 43993 Scheele

Laboratories

Phils.,Inc.

16-Apr-14 Notified

14 04 16 2907 Cefuroxime (as sodium) Kefox 750 0008910 PharmAsia-Cuvest,

Inc.

16-Apr-14 Notified

14 04 16 2908 Cefalexin (as monohydrate) 150323 Pascual

Laboratories, Inc.

16-Apr-14 Notified

14 04 16 2909 Clarithromycin 5163DAA Pascual

Laboratories, Inc.

16-Apr-14 Notified

14 04 16 2910 Cefaclor (as monohydrate) Ceclobid 150316 The Cathay YSS

Distributors Co., Inc.

16-Apr-14 Notified

14 04 16 2911 Cefaclor (as monohydrate) Ceclobid 150317 The Cathay YSS

Distributors Co., Inc.

16-Apr-14 Notified

14 04 16 2912 Clarithromycin Clarithrocid 141205 The Cathay Drug

Co., Inc.

16-Apr-14 Notified

14 04 16 2913 Ticarcillin (as disodium) + Clavulanic Acid

(as clavulanate potassium)

Triclav 12014C YSS Laboratories

Co.,Inc.

16-Apr-14 Notified

14 04 16 2914 Streptomycin Sulfate P143033 The Cathay Drug

Co., Inc.

16-Apr-14 Notified

14 04 16 2915 Cefuroxime (as axetil) Sqcef 14D151 Square

Pharmaceuticals,

Inc.

16-Apr-14 Notified

14 04 16 2916 Cefuroxime (as axetil) Acrocef 14D163 Square

Pharmaceuticals,

Inc.

16-Apr-14 Notified

14 04 16 2917 Amoxicillin (as trihydrate) Macromox 423046 La Croesus Pharma,

Inc.

16-Apr-14 Notified

14 04 16 2918 Cefoperazone Sodium / Sulbactam Sodium Sulperazone 13922600R Pfizer, Inc. 16-Apr-14 Notified

14 04 16 2919 Cefuroxime (as axetil) Clecef T4001 Sel-J

Pharmaceuticals and

Distributor

16-Apr-14 Notified

14 04 16 2920 Cefuroxime (as axetil) Clecef T4002 Sel-J

Pharmaceuticals and

Distributor

16-Apr-14 Notified

14 04 16 2921 Cefuroxime (as axetil) Clecef T4003 Sel-J

Pharmaceuticals and

Distributor

16-Apr-14 Notified

Page 23 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 16 2922 Cefuroxime (as axetil) Clecef T4004 Sel-J

Pharmaceuticals and

Distributor

16-Apr-14 Notified

14 04 16 2923 Cefuroxime (as axetil) Clecef T4005 Sel-J

Pharmaceuticals and

Distributor

16-Apr-14 Notified

14 04 16 2924 Cefuroxime (as axetil) Zurenix B254 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2925 Cefuroxime (as axetil) Zurenix B255 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2926 Cefuroxime (as axetil) Zurenix B256 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2927 Cefuroxime (as sodium) Zurenix B814A Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2928 Cefuroxime (as sodium) Zurenix B502C Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2929 Cefalexin (as monohydrate) Falteria 500 B879 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2930 Cefalexin (as monohydrate) Falteria 500 B935 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2931 Cefalexin (as monohydrate) Falteria 500 B936 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2932 Cefalexin (as monohydrate) Falteria 500 B937 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 16 2933 Cefalexin (as monohydrate) Falteria 500 B938 Pasteur

Pharmaceutical

Sales

21-Apr-14 Notified

14 04 22 2934 Tobramycin / Dexamethasone Tobradex 14B25A Alcon Laboratories

(Phils.) Inc.

23-Apr-14 Notified

14 04 22 2935 Clarithromycin Clarithrocid 150309 The Cathay Drug

Co., Inc.

23-Apr-14 Notified

14 04 22 2936 Cefuroxime (as sodium) Profurex P142021 The Cathay Drug

Co., Inc.

23-Apr-14 Notified

14 04 22 2937 Cefuroxime (as axetil) Xyfrox BK41130 J.M. Tolmann

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2938 Cefuroxime (as axetil) Xyfrox BK43131 J.M. Tolmann

Laboratories, Inc.

23-Apr-14 Notified

Page 24 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 22 2939 Cefuroxime (as axetil) Roxime BT-32038 Health Saver

Pharma Inc.

23-Apr-14 Notified

14 04 22 2940 Cefalexin (as monohydrate) Cepham PDB087 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2941 Cefalexin (as monohydrate) Cepham PDB086 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2942 Cefalexin (as monohydrate) Cepham PDB085 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2943 Cefixime (as trihydrate) Myrecef PDB090 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2944 Cefixime (as trihydrate) Flexime PDB091 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2945 Meropenem Trihydrate Meronem KR331 (Lot

No.on crimp:

2B13C08)

AstraZeneca

Pharmaceuticals

(Phils.), Inc.

23-Apr-14 Notified

14 04 22 2946 Meropenem Trihydrate Meronem KR214 (Lot

No.on crimp:

1A13F04)

AstraZeneca

Pharmaceuticals

(Phils.), Inc.

23-Apr-14 Notified

14 04 22 2947 Cefalexin (as monohydrate) CEF-500 14BCEF01 Brymar

Pharmaceuticals

23-Apr-14 Notified

14 04 22 2948 Cefalexin (as monohydrate) Ivynall 14BIC01 Brymar

Pharmaceuticals

23-Apr-14 Notified

14 04 22 2949 Cefuroxime (as axetil) Sqcef 14D141 Square

Pharmaceuticals,

Inc.

23-Apr-14 Notified

14 04 22 2950 Cefuroxime (as axetil) Sqcef 14D164 Square

Pharmaceuticals,

Inc.

23-Apr-14 Notified

14 04 22 2951 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8130C YSS Laboratories

Co.,Inc.

23-Apr-14 Notified

14 04 22 2952 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8131C YSS Laboratories

Co.,Inc.

23-Apr-14 Notified

14 04 22 2953 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8129C YSS Laboratories

Co.,Inc.

23-Apr-14 Notified

14 04 22 2954 Cefixime (as trihydrate) Taxim-O Forte 4120199 Alkem Laboratories,

Corp.

23-Apr-14 Notified

14 04 22 2955 Co-Amoxiclav Alclav 4150088 Alkem Laboratories,

Corp.

23-Apr-14 Notified

14 04 22 2956 Cefuroxime (as axetil) Zocef 4120047 Alkem Laboratories,

Corp.

23-Apr-14 Notified

14 04 22 2957 Cefuroxime (as axetil) Zocef 4120048 Alkem Laboratories,

Corp.

23-Apr-14 Notified

14 04 22 2958 Cefalexin Ceporex 14CXGN-1 Interphil

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2959 Clindamycin HCl Dalacin C 14DCPR2 Interphil

Laboratories, Inc.

23-Apr-14 Notified

14 04 22 2960 Co-Amoxiclav Megaclav 4C262A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2961 Cloxacillin (as sodium) Cloxil 4B479A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

Page 25 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 22 2962 Co-Amoxiclav Clovimax 4C181A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2963 Cefuroxime (as axetil) Zinaxime 4C362A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2964 Amoxicillin (as trihydrate) Eleomox 4C174A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2965 Cefalexin (as monohydrate) Lexriel 4B063A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2966 Amoxicillin (as trihydrate) Altomox 4B375A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2967 Cefradine (as monohydrate) Cefralon 4C336A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2968 Co-Amoxiclav Mediclav 4B481A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2969 Doxycycline (as hyclate) Aldoxy 4B007A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2970 Flucloxacillin (as sodium) Coxafen 4C163A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2971 Sultamicillin (as tosylate) Sultamin 4C044A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2972 Co-Amoxiclav Natravox 14NT602 Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2973 Rifampicin + Isoniazid + Ethambutol Fixcom 3 14FXC3 05 Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2974 Rifampicin Natricin Forte 14NF 12 Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2975 Rifampicin + Isoniazid + Ethambutol Fixcom 3 14FXC3 04 Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2976 Clindamycin (as hydrochloride) Myclin PB9305 Endure Medical, Inc. 23-Apr-14 Notified

14 04 22 2977 Co-Amoxiclav Globantin C4020851 Global Pharmatrade 23-Apr-14 Notified

14 04 22 2978 Clindamycin (as hydrochloride) Myclin PB9307A Endure Medical, Inc. 23-Apr-14 Notified

14 04 22 2979 Piperacillin Sodium + Tazobactam Sodium Tazobak XB-13173 International Apex

Pharmaceuticals,

Inc.

23-Apr-14 Notified

14 04 22 2980 Clindamycin (as hydrochloride) Myclin PB9306 Endure Medical, Inc. 23-Apr-14 Notified

14 04 22 2981 Co-Amoxiclav Globantin C4020821 Global Pharmatrade 23-Apr-14 Notified

14 04 22 2982 Cefuroxime Axetil Pheoronex PXTA4C1 Next Chemical

Enterprises

23-Apr-14 Notified

14 04 22 2983 Cefuroxime Axetil Pheoronex PXTA4C2 Next Chemical

Enterprises

23-Apr-14 Notified

14 04 22 2984 Azithromycin (as monohydrate) Pediazith 3K343A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2985 Azithromycin (as monohydrate) Pediazith 3K343A Lloyd Laboratories,

Inc.

23-Apr-14 Notified

14 04 22 2986 Co-Amoxiclav Augmentin 665011 GlaxoSmithKline

Philippines Inc.

23-Apr-14 Notified

Page 26 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 22 2987 Mupirocin Bactroban 3BA109A GlaxoSmithKline

Philippines Inc.

23-Apr-14 Notified

14 04 22 2988 Mupirocin Bactroban 4BA19 GlaxoSmithKline

Philippines Inc.

23-Apr-14 Notified

14 04 22 2989 Mupirocin Bactroban 4BA22 GlaxoSmithKline

Philippines Inc.

23-Apr-14 Notified

14 04 22 2990 Mupirocin Bactroban 4BC07 GlaxoSmithKline

Philippines Inc.

23-Apr-14 Notified

14 04 23 2991 Gentamicin (as sulfate) Lormigin 514046 Lordla Pharma Sales 23-Apr-14 Notified

14 04 23 2992 Clindamycin (as hydrochloride) Dalacin C 429-58007 Pfizer, Inc. 23-Apr-14 Notified

14 04 23 2993 Azithromycin (as dihydrate) Zithromax Z299701 Pfizer, Inc. 23-Apr-14 Notified

14 04 23 2994 Cloxacillin (as sodium) Kloxitas A 1413 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 2995 Cloxacillin (as sodium) Kloxitas A 1412 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 2996 Cloxacillin (as sodium) Kloxitas A 1411 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 2997 Cloxacillin (as sodium) Kloxitas A 1410 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 2998 Cloxacillin (as sodium) Kloxitas A 1408 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 2999 Cloxacillin (as sodium) Kloxitas A 1407 Suhitas

Pharmaceuticals Inc.

23-Apr-14 Notified

14 04 23 3000 Erythromycin (as stearate) 5029BWA Pascual

Laboratories, Inc.

23-Apr-14 Notified

14 04 23 3001 Cefotaxime (as sodium) Claforan 113839 Sanofi-aventis

Philippines Inc.

23-Apr-14 Notified

14 04 23 3002 Erythromycin (as ethylsuccinate) Mythrocin PDB126 New Myrex

Laboratories, Inc.

23-Apr-14 Notified

14 04 23 3003 Cefixime (as trihydrate) Citroen P0144024 Euro Generics

International Phils.,

Inc.

24-Apr-14 Notified

14 04 23 3004 Cefixime (as trihydrate) Citroen P0144023 Euro Generics

International Phils.,

Inc.

24-Apr-14 Notified

14 04 23 3005 Polymyxin B Sulfate + Neomycin Sulfate +

Dexamethasone

Postotic 4H102 Sensomed Phils.

Inc.

24-Apr-14 Notified

14 04 23 3006 Tobramycin 4H103 Sensomed Phils.

Inc.

24-Apr-14 Notified

14 04 23 3007 Tobramycin / Dexamethasone 4H104 Sensomed Phils.

Inc.

24-Apr-14 Notified

14 04 23 3008 Chloramphenicol 4F138 Sensomed Phils.

Inc.

24-Apr-14 Notified

Page 27 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 23 3009 Co-Amoxiclav Clavic 4C246A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3010 Cefalexin (as monohydrate) Lorecep 4C402A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3011 Clindamycin (as hydrochloride) Zindal 300 4C061A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3012 Co-Amoxiclav Clavic 4C246A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3013 Co-Amoxiclav Altovox 4C284A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3014 Co-Amoxiclav Megaclav 4C261A Lloyd Laboratories,

Inc.

24-Apr-14 Notified

14 04 23 3015 Chloramphenicol (as palmitate) C-Phenicol 4C210 Terramedic, Inc. 24-Apr-14 Notified

14 04 23 3016 Amoxicillin (as trihydrate) Amorex 4C234 Drugmaker's

Laboratories, Inc.

24-Apr-14 Notified

14 04 23 3017 Ceftriaxone Sodium Pneumosolv 020114 JustRight

Pharmaceuticals

24-Apr-14 Notified

14 04 23 3018 Ceftriaxone Sodium Pneumosolv 010114 JustRight

Pharmaceuticals

24-Apr-14 Notified

14 04 23 3019 Ceftriaxone Sodium Pneumosolv 030114 JustRight

Pharmaceuticals

24-Apr-14 Notified

14 04 23 3020 Cefuroxime (as axetil) Cimex 404004 Multicare

Pharmaceuticals

Phils.,Inc.

24-Apr-14 Notified

14 04 23 3021 Cefuroxime Axetil Cimex 404002 Multicare

Pharmaceuticals

Phils.,Inc.

24-Apr-14 Notified

14 04 23 3022 Cefuroxime Axetil Cimex 404001 Multicare

Pharmaceuticals

Phils.,Inc.

24-Apr-14 Notified

14 04 23 3023 Clarithromycin Klarimed B293 Pasteur

Pharmaceutical

Sales

24-Apr-14 Notified

14 04 23 3024 Clarithromycin Clarithrocid 150231 The Cathay Drug

Co., Inc.

24-Apr-14 Notified

14 04 23 3025 Ceftriaxone (as sodium) Ceftrox 42M1310 Singapore

Pharmawealth

Lifesciences, Inc.

24-Apr-14 Notified

14 04 23 3026 Cefalexin (as monohydrate) Madexin 403019 Medic Aid

Distributors, Inc.

24-Apr-14 Notified

14 04 23 3027 Cefalexin Madexin 402064 Medic Aid

Distributors, Inc.

24-Apr-14 Notified

14 04 24 3028 Cefalexin Monohydrate Zelexin 14C4305 Am-Europharma

Corporation

25-Apr-14 Notified

14 04 24 3029 Cefalexin Diacef 27042 Diamond

Laboratories, Inc.

25-Apr-14 Notified

14 04 24 3030 Amoxicillin (as trihydrate) Moxylor B07035 Diamond

Laboratories, Inc.

25-Apr-14 Notified

14 04 24 3031 Co-Amoxiclav Augmentin 167B GlaxoSmithKline

Philippines Inc.

25-Apr-14 Notified

Page 28 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 24 3032 Co-Amoxiclav Augmentin ES 1021 GlaxoSmithKline

Philippines Inc.

25-Apr-14 Notified

14 04 24 3033 Cefalexin (as monohydrate) Oneflex OPOU2-011 One Pharma

Co.,Inc.

25-Apr-14 Notified

14 04 24 3034 Amoxicillin (as trihydrate) Globapen GXU7-103 GX International,

Inc.

25-Apr-14 Notified

14 04 24 3035 Amoxicillin (as trihydrate) Vhellox 500 B742 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3036 Amoxicillin (as trihydrate) Vhellox 500 B744 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3037 Amoxicillin (as trihydrate) Vhellox 500 B743 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3038 Amoxicillin (as trihydrate) Vhellox 500 B741 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3039 Amoxicillin (as trihydrate) Vhellox 500 B740 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3040 Amoxicillin (as trihydrate) Vhellox 500 B709 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3041 Amoxicillin (as trihydrate) Vhellox 500 B708 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3042 Amoxicillin (as trihydrate) Vhellox 500 B706 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3043 Amoxicillin (as trihydrate) Vhellox 500 B657 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3044 Amoxicillin (as trihydrate) Vhellox 500 B656 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3045 Amoxicillin (as trihydrate) Vhellox 500 B705 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3046 Amoxicillin (as trihydrate) Vhellox 500 B707 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3047 Cefalexin (as monohydrate) Falteria 500 B876 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3048 Cefalexin (as monohydrate) Falteria 500 B877 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3049 Cefalexin (as monohydrate) Falteria 500 B878 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

Page 29 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 24 3050 Amoxicillin (as trihydrate) Vhellox 250 B955 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3051 Amoxicillin (as trihydrate) Vhellox 250 B957 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3052 Amoxicillin (as trihydrate) Vhellox 250 B958 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3053 Erythromycin (as stearate) Pertustat 500 B808 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3054 Erythromycin (as stearate) Pertustat 500 B809 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3055 Erythromycin (as stearate) Pertustat 500 B810 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3056 Erythromycin (as stearate) Pertustat 500 B811 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3057 Cefalexin (as monohydrate) Falteria 500 B874 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3058 Cefalexin (as monohydrate) Falteria 500 B875 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3059 Co-Amoxiclav Clavistan 625 B783 Pasteur

Pharmaceutical

Sales

25-Apr-14 Notified

14 04 24 3060 Amoxicillin Pediamox A016040 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3061 Amoxicillin Pediamox A016061 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3062 Amoxicillin Pediamox A016039 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3063 Cefixime Ultraxime A016010 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3064 Amoxicillin Pediamox A015984 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3065 Cefaclor A015994 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3066 Cefaclor A015977 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3067 Amoxicillin Himox A015950 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3068 Amoxicillin Himox A016001 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3069 Amoxicillin A016083 Asian Antibiotics,

Inc.

25-Apr-14 Notified

Page 30 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 24 3070 Amoxicillin A016080 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3071 Amoxicillin A016081 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3072 Amoxicillin Himox A016015 Asian Antibiotics,

Inc.

25-Apr-14 Notified

14 04 24 3073 Co-Amoxiclav Amoclav 4141011A Pediatrica, Inc. 25-Apr-14 Notified

14 04 24 3074 Co-Amoxiclav Amoclav 4139011A Pediatrica, Inc. 25-Apr-14 Notified

14 04 24 3075 Cefuroxime (as axetil) Rocef E424 Ambica Intenational

Trading Corporation

25-Apr-14 Notified

14 04 24 3076 Cefuroxime (as axetil) Cefwin-500 C1208 Ambica Intenational

Trading Corporation

25-Apr-14 Notified

14 04 24 3077 Cefuroxime (as axetil) Rocef E422 Ambica Intenational

Trading Corporation

25-Apr-14 Notified

14 04 24 3078 Cefuroxime (as axetil) Rocef E423 Ambica Intenational

Trading Corporation

25-Apr-14 Notified

14 04 24 3079 Cefixime (as trihydrate) Ofex 200 008 Biomed Pharma Inc. 25-Apr-14 Notified

14 04 24 3080 Amoxicillin (as trihydrate) Medimoxil 73 / BAX5066 MG Prime

Pharmaceutical Inc.

25-Apr-14 Notified

14 04 24 3081 Amoxicillin (as trihydrate) Medimoxil 74 / BAX4060 MG Prime

Pharmaceutical Inc.

25-Apr-14 Notified

14 04 24 3082 Amoxicillin (as trihydrate) Medimoxil 75 / BAX4061 MG Prime

Pharmaceutical Inc.

25-Apr-14 Notified

14 04 24 3083 Co-Amoxiclav Comox 4C291A Lloyd Laboratories,

Inc.

25-Apr-14 Notified

14 04 24 3084 Cefalexin (as monohydrate) Medoxine 4D066A Lloyd Laboratories,

Inc.

25-Apr-14 Notified

14 04 29 3085 Clarithromycin Klaricid 39152XP Abbott Laboratories

(Philippines)

29-Apr-14 Notified

14 04 29 3086 Cefepime HCl Sefpime 140221 Dynasty

Pharmaceuticals

29-Apr-14 Notified

14 04 29 3087 Amoxicillin (as trihydrate) Biomox 4D100 Biotech Research

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3088 Cefixime (as trihydrate) Taxim-O 3122616 Alkem Laboratories,

Corp.

29-Apr-14 Notified

14 04 29 3089 Cefuroxime (as axetil) Zocef 4120230 Alkem Laboratories,

Corp.

29-Apr-14 Notified

14 04 29 3090 Piperacillin (as sodium) + Tazobactam (as

sodium)

Pipzo 4150113 Alkem Laboratories,

Corp.

29-Apr-14 Notified

14 04 29 3091 Cefuroxime (as sodium) Zocef 4120281 Alkem Laboratories,

Corp.

29-Apr-14 Notified

14 04 29 3092 Clarithromycin Clarbact FUT4001 Blue Global (FZE) 29-Apr-14 Notified

14 04 29 3093 Clarithromycin Clarbact FUT4002 Blue Global (FZE) 29-Apr-14 Notified

14 04 29 3094 Clarithromycin Clarbact 4002 Blue Global (FZE) 29-Apr-14 Notified

14 04 29 3095 Ceftriaxone (as sodium) Sitixon 131103 Sahar International

Trading Inc.

29-Apr-14 Notified

14 04 29 3096 Cefuroxime Sodium Danoxime 131102 Sahar International

Trading Inc.

29-Apr-14 Notified

Page 31 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 29 3097 Meropenem Aropen 14A01 Sahar International

Trading Inc.

29-Apr-14 Notified

14 04 29 3098 Meropenem Aropen 14A02 Sahar International

Trading Inc.

29-Apr-14 Notified

14 04 29 3099 Meropenem Aropen 14A01 Sahar International

Trading Inc.

29-Apr-14 Notified

14 04 29 3100 Clarithromycin Klaz M085116 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3101 Clarithromycin Klaz M083802 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3102 Doxycyline (as hyclate) Doxin M084543 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3103 Doxycyline (as hyclate) Doxin M084544 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3104 Doxycyline (as hyclate) Doxin M084545 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3105 Rifampicin + Isoniazid Bifix M083487 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3106 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083900 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3107 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083898 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3108 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083897 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3109 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083896 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3110 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083895 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3111 Rifampicin + Isoniazid + Ethambutol HCl Tritab M083899 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3112 Bacitracin + Polymyxin B + Neomycin Trimycin M4362 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3113 Doxycycline (as hyclate) Doxin M084546 Amherst

Laboratories, Inc.

29-Apr-14 Notified

14 04 29 3114 Amoxicillin (as trihydrate) 9553 JB Orchid

Pharmaceuticals,

Inc.

29-Apr-14 Notified

14 04 29 3115 Cefuroxime Zoltax 4002A Natrapharm, Inc. 29-Apr-14 Notified

14 04 29 3116 Clindamycin (as hydrochloride) Dalacin C 429-58008 Pfizer, Inc. 29-Apr-14 Notified

14 04 29 3117 Azithromycin (as dihydrate) Zithromax 141464033 Pfizer, Inc. 29-Apr-14 Notified

14 04 29 3118 Cefixime Tergecef OD A015958 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3119 Amoxicillin Himox A016113 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3120 Amoxicillin A016054 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3121 Amoxicillin A016084 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3122 Cloxacillin Sodium A016088 Asian Antibiotics,

Inc.

30-Apr-14 Notified

Page 32 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 29 3123 Cloxacillin Sodium A016089 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3124 Cloxacillin Sodium A016087 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3125 Cefaclor A015955 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3126 Cefixime Ultraxime A015982 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3127 Cefixime Ultraxime A016009 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3128 Amoxicillin A016037 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3129 Amoxicillin A016022 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3130 Flucloxacillin Magnesium Stafloxin A015666 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3131 Amoxicillin Himox A016016 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3132 Azithromycin Monohydrate Zenith EC1484 Pediatrica, Inc. 30-Apr-14 Notified

14 04 29 3133 Amoxicillin Himox A016014 Asian Antibiotics,

Inc.

30-Apr-14 Notified

14 04 29 3134 Azithromycin Monohydrate Zenith EC1486 Pediatrica, Inc. 30-Apr-14 Notified

14 04 29 3135 Azithromycin Monohydrate Zenith EC1482 Pediatrica, Inc. 30-Apr-14 Notified

14 04 29 3136 Azithromycin Monohydrate Zenith EC1483 Pediatrica, Inc. 30-Apr-14 Notified

14 04 29 3137 Cefalexin (as monohydrate) Forexine GCF5B-015 GX International,

Inc.

30-Apr-14 Notified

14 04 29 3138 Rifampicin + Isoniazid Rimactazid 1402 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3139 Cefalexin (as monohydrate) Falteria 500 B871 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3140 Cefalexin (as monohydrate) Falteria 500 B872 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3141 Cefalexin (as monohydrate) Falteria 500 B873 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3142 Cefalexin (as monohydrate) Falteria 500 B962 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3143 Cefalexin (as monohydrate) Falteria 500 B961 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3144 Cefalexin (as monohydrate) Falteria 500 B940 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3145 Cefalexin (as monohydrate) Falteria 500 B939 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

Page 33 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 29 3146 Amoxicillin (as trihydrate) Vhellox 500 B746 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3147 Amoxicillin (as trihydrate) Vhellox 500 B745 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3148 Cefalexin (as monohydrate) Falteria 500 B651 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3149 Amoxicillin (as trihydrate) Vhellox 500 B749 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3150 Amoxicillin (as trihydrate) Vhellox 500 B748 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3151 Amoxicillin (as trihydrate) Vhellox 500 B747 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3152 Amoxicillin (as trihydrate) Vhellox 500 B751 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3153 Amoxicillin (as trihydrate) Vhellox 500 B750 Pasteur

Pharmaceutical

Sales

30-Apr-14 Notified

14 04 29 3154 Co-Amoxiclav Augmentin ES 988 GlaxoSmithKline

Philippines Inc.

30-Apr-14 Notified

14 04 29 3155 Cefuroxime (as sodium) Zinacef 4801 GlaxoSmithKline

Philippines Inc.

30-Apr-14 Notified

14 04 29 3156 Co-Amoxiclav Augmentin ES 1005 GlaxoSmithKline

Philippines Inc.

30-Apr-14 Notified

14 04 29 3157 Cefaclor (as monohydrate) Clormed AH4262 Meedpharma

Medical Supplies

30-Apr-14 Notified

14 04 29 3158 Amoxicillin (as trihydrate) 42443G J.M. Tolmann

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3159 Amoxicillin (as trihydrate) 42343G J.M. Tolmann

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3160 Amoxicillin (as trihydrate) 42243G J.M. Tolmann

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3161 Amoxicillin (as trihydrate) 42143G J.M. Tolmann

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3162 Gentamicin Servigenta 10977610 Sandoz Philippines

Corp.

30-Apr-14 Notified

14 04 29 3163 Azithromycin (as monohydrate) Azyth EB4451 Sandoz Philippines

Corp.

30-Apr-14 Notified

14 04 29 3164 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8132C YSS Laboratories

Co.,Inc.

30-Apr-14 Notified

14 04 29 3165 Meropenem Trihydrate Meromax 9072 YSS Laboratories

Co.,Inc.

30-Apr-14 Notified

14 04 29 3166 Co-Amoxiclav Bactiv 6043M YSS Laboratories

Co.,Inc.

30-Apr-14 Notified

Page 34 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 29 3167 Piperacillin (as sodium) + Tazobactam (as

sodium)

Vigocid 8133C YSS Laboratories

Co.,Inc.

30-Apr-14 Notified

14 04 29 3168 Co-Amoxiclav Bioclavid EC0954 Sandoz Philippines

Corp.

30-Apr-14 Notified

14 04 29 3169 Co-Amoxiclav Moxsan B3209 SRS

Pharmaceuticals,

Phils. Inc.

30-Apr-14 Notified

14 04 29 3170 Co-Amoxiclav 4181022A RiteMed Phils Inc. 30-Apr-14 Notified

14 04 29 3171 Co-Amoxiclav 4181021A RiteMed Phils Inc. 30-Apr-14 Notified

14 04 29 3172 Co-Amoxiclav Bioclavid EB3094 Sandoz Philippines

Corp.

30-Apr-14 Notified

14 04 29 3173 Amoxicillin (as trihydrate) Benedex PDB163 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3174 Amoxicillin (as trihydrate) Benedex PDB164 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3175 Amoxicillin (as trihydrate) Benedex PDB165 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3176 Doxycycline (as hyclate) Mydoxy PDB209 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3177 Amoxicillin (as trihydrate) Benedex PDB166 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3178 Cefaclor (as monohydrate) Vitaclor PDB227 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3179 Cefaclor (as monohydrate) Vitaclor PDB227 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3180 Cefalexin (as monohydrate) Cepham PDB088 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3181 Cefalexin (as monohydrate) Cepham PDB089 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3182 Cefuroxime (as axetil) Zoltax 14Z2 03 Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3183 Clindamycin Clindaxin 4C248A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3184 Amoxicillin (as trihydrate) Acumox 4C062A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3185 Chloramphenicol Micromycetin 4A476A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3186 Cefalexin (as monohydrate) Lexibase 4C068A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3187 Clarithromycin Klarithix KLA301 MedEthix, Inc. 30-Apr-14 Notified

14 04 29 3188 Cefalexin (as monohydrate) Voxxim PDB092 Roddensers

Pharmaceuticals

30-Apr-14 Notified

14 04 29 3189 Erythromycin Mythrocin PDB161 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3190 Clindamycin (as hydrochloride) Clin-Gen PDB208 New Myrex

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3191 Co-Amoxiclav Natravox 14NS411 Lloyd Laboratories,

Inc.

30-Apr-14 Notified

Page 35 of 36

BATCH NOTIFICATION 2014

YR MO DABN

NumberGENERIC NAME BRAND NAME BATCH/ LOT NUMBER COMPANY APPLICANT DATE RELEASED REMARKS

DATE/CODE PRODUCT INFORMATION OTHER INFORMATION

14 04 29 3192 Clarithromycin Clariget 111F02 Getz Pharma Phils.,

Inc.

30-Apr-14 Notified

14 04 29 3193 Clarithromycin Clariget 112F01 Getz Pharma Phils.,

Inc.

30-Apr-14 Notified

14 04 29 3194 Clarithromycin Clariget 117F02 Getz Pharma Phils.,

Inc.

30-Apr-14 Notified

14 04 29 3195 Clarithromycin Clariget 331D01 Getz Pharma Phils.,

Inc.

30-Apr-14 Notified

14 04 29 3196 Cefradine (as monohydrate) Altozef 4C197A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3197 Co-Amoxiclav Inoclav 4C200A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3198 Co-Amoxiclav Lactamox 4C420A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3199 Co-Amoxiclav Clovimed 4C242A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3200 Erythromycin (as ethylsuccinate) Aldricin 4C192A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3201 Co-Amoxiclav Natravox 14NS411 Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3202 Rifampicin + Isoniazid + Pyrazinamide +

Ethambutol

Fixcom 4 14FXC4 07 Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3203 Co-Amoxiclav Clavoxin 4B411A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3204 Cefuroxime (as axetil) Zinaxime 4C362A Lloyd Laboratories,

Inc.

30-Apr-14 Notified

14 04 29 3205 Cefalexin Ceporex 14CPRX-1 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3206 Cefalexin Ceporex 14CG-6 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3207 Clarithromycin Clarid 14CLA-2 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3208 Polymyxin B Sulfate + Bacitracin Zinc +

Neomycin Sulfate

Terramycin 14TERRP1 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3209 Cefalexin Ceporex 14CG-6A Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3210 Cefaclor Ceclor 14CLL-1 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3211 Cefaclor Ceclor 14CLG-1 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3212 Cefalexin Ceporex 14CXGN-2 Interphil

Laboratories, Inc.

30-Apr-14 Notified

14 04 29 3213 Clarithromycin Clarimid 14CLMT-1 Interphil

Laboratories, Inc.

30-Apr-14 Notified

Page 36 of 36