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Consolidated Pharma Data Platform, see what is new over the past 30 days.

WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources. The data feeds run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.

33 FDA CDER quality inspections posted in last 60 days

This is updated weekly with the latest FDA inspections.

Company City Country Inspection End Date Project Area Classification
BIOMEDIC SYSTEMS INC San Juan US 2019-10-04 Drug Quality Assurance VAI
Alexza Pharmaceutica Mountain View US 2019-09-26 Drug Quality Assurance NAI
Sawai Pharmaceutical Kamisu JP 2019-10-15 Drug Quality Assurance VAI
Amphastar Nanjing Ph Nanjing CN 2019-10-11 Drug Quality Assurance VAI
Beijing Zhangguang 1 Beijing CN 2019-09-27 Drug Quality Assurance VAI
Phoenix Innovative H Navi Mumbai IN 2019-09-27 Drug Quality Assurance NAI
Oncotec Pharma Produ Dessau Rosslau DE 2019-09-27 Drug Quality Assurance VAI
Lusomedicamenta Soci Barcarena PT 2019-09-27 Drug Quality Assurance VAI
IMS srl, Micronizzaz Milan IT 2019-09-27 Drug Quality Assurance NAI
Centaur Pharmaceutic Ambernath IN 2019-09-27 Drug Quality Assurance VAI
Qilu Pharmaceutical Jinan CN 2019-09-27 Drug Quality Assurance NAI
Interquim S.A. Sant Cugat Del Valles ES 2019-09-27 Drug Quality Assurance VAI
Novartis Pharma Prod Wehr DE 2019-09-27 Drug Quality Assurance NAI
Grillo Zinkoxid GmbH Goslar DE 2019-09-26 Drug Quality Assurance VAI
S.I.P.R.E.S. Srl Limena IT 2019-09-26 Drug Quality Assurance VAI
MSD International Gm Singapore SG 2019-09-26 Drug Quality Assurance NAI
Cosmetic Manufacture Helensvale AU 2019-09-25 Drug Quality Assurance NAI
Isomers Laboratories North York CA 2019-09-25 Drug Quality Assurance VAI
Labena d.o.o. Ljubljana SI 2019-09-24 Drug Quality Assurance NAI
Bayer AG Berlin DE 2019-09-24 Drug Quality Assurance VAI
Nature's Natural Pro Nashville US 2019-09-27 Drug Quality Assurance VAI
The Micro Connection City Of Industry US 2019-10-30 Drug Quality Assurance VAI
AirGas USA, LLC Pomona US 2019-10-18 Drug Quality Assurance NAI
Airgas USA LLC Los Angeles US 2019-10-09 Drug Quality Assurance NAI
Natren, Inc. Thousand Oaks US 2019-10-08 Drug Quality Assurance VAI
RD2RX, LLC Lenexa US 2019-10-03 Drug Quality Assurance NAI
Eurofins EAG Materia Maryland Heights US 2019-09-24 Drug Quality Assurance VAI
Airgas USA, LLC Miami US 2019-10-18 Drug Quality Assurance VAI
Tuscano and Delucia Salt Lake City US 2019-09-26 Drug Quality Assurance VAI
DPT Laboratories, Lt San Antonio US 2019-10-23 Drug Quality Assurance NAI
Oakwood Laboratories Oakwood Village US 2019-10-08 Drug Quality Assurance NAI
Bajaj Medical, LLC Chicago US 2019-10-01 Drug Quality Assurance VAI
Beaumont Products In Kennesaw US 2019-10-08 Drug Quality Assurance NAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Cipla Limited India 2019-09-27
Aurobindo Pharma Ltd. India 2019-09-27

Latest FDA warning letters below, this is updated weekly with the latest FDA warning letters.

Company Issue Date Office Link
Dr Jen Hartley/Heali 2019-10-29 Division of Pharmaceutical Quality Operations IV
The Vapor Hut, LLC 2019-10-25 Center for Tobacco Products
CueCig 2019-10-24 Center for Tobacco Products
Eonsmoke, LLC 2019-10-24 Center for Tobacco Products
E-Cigarette-Mart.com 2019-10-25 Center for Tobacco Products

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
AvPAK oral metronidazole 500 mg/1 50268-535-15 ANDA 2019-10-30
AvPAK oral metronidazole 250 mg/1 50268-534-15 ANDA 2019-10-30
HF Acquisition parenteral dextrose 500 mg/mL 51662-1380-1 UNAPPROVED DRUG OTHER 2019-10-29
HF Acquisition epidural, infiltration, intracaudal, perineural chloroprocaine hci 20 mg/mL 51662-1408-1 NDA 2019-10-29
HF Acquisition intramuscular, intravenous, subcutaneous nalbuphine hci 20 mg/mL 51662-1418-1 ANDA 2019-10-29
HF Acquisition intravenous lidocaine hci 20 mg/mL 51662-1382-1 ANDA 2019-10-29
Mayne Pharma In oral budesonide 3 mg/1 51862-580-01 ANDA 2019-10-31
Mayne Pharma oral diazepam 2 mg/1 51862-941-05, 51862-941-01 ANDA 2019-10-31
Mayne Pharma oral diazepam 10 mg/1 51862-943-01, 51862-943-05, 51862-943-10 ANDA 2019-10-31
Breckenridge Ph oral erlotinib hydrochloride 25 mg/1 51991-890-33 ANDA 2019-11-05
HF Acquisition intramuscular, intravenous, subcutaneous nalbuphine hci 10 mg/mL 51662-1420-1 ANDA 2019-10-29
Mayne Pharma oral diazepam 5 mg/1 51862-942-01, 51862-942-05, 51862-942-10 ANDA 2019-10-31
Breckenridge Ph oral erlotinib hydrochloride 100 mg/1 51991-891-33 ANDA 2019-11-05
Breckenridge Ph oral erlotinib hydrochloride 150 mg/1 51991-892-33 ANDA 2019-11-05
Wilshire Pharma auricular (otic) ciprofloxacin and fluocinolone acetonide .75 mg/.25mL, .0625 mg/.25mL 52536-080-14 NDA 2019-11-01
General Injecta epidural, infiltration, intracaudal, perineural bupivacaine hydrochloride and epinephrine bitartrate 2.5 mg/mL, .0091 mg/mL 52584-746-71 NDA 2019-11-04
Hainan Shuangch intravenous bivalirudin 250 mg/1 52958-034-01 ANDA 2019-10-28
AuroMedics Phar intramuscular, intravenous, subcutaneous naloxone hydrochloride .4 mg/mL 55150-328-10, 55150-328-25 ANDA 2019-11-04
Quality Care Pr transdermal fentanyl 75 ug/h 55700-811-05 ANDA 2019-10-25
Amgen Inc intravenous trastuzumab-anns 150 mg/7.15mL 55513-141-01 BLA 2019-10-28
Apotex Corp. oral cyclosporine 50 mg/1 60505-4631-3 ANDA 2019-11-05
Apotex Corp. oral cyclosporine 25 mg/1 60505-4630-3 ANDA 2019-11-05
Apotex Corp. oral carvedilol phosphate 20 mg/1 60505-4714-3 NDA AUTHORIZED GENERIC 2019-11-01
St. Mary's Medi oral cyclobenzaprine hydrochloride 7.5 mg/1 60760-363-60, 60760-363-90, 60760-363-92 ANDA 2019-10-24
Apotex Corp. oral cyclosporine 100 mg/1 60505-4632-3 ANDA 2019-11-05
Apotex Corp. oral carvedilol phosphate 40 mg/1 60505-4715-3 NDA AUTHORIZED GENERIC 2019-11-01
American Health oral nitrofurantoin 100 mg/1 60687-483-01 ANDA 2019-10-28
Apotex Corp. oral carvedilol phosphate 80 mg/1 60505-4716-3 NDA AUTHORIZED GENERIC 2019-11-01
Apotex Corp. oral carvedilol phosphate 10 mg/1 60505-4713-3 NDA AUTHORIZED GENERIC 2019-11-01
American Health oral nitrofurantoin 50 mg/1 60687-472-01 ANDA 2019-10-28
American Health oral clonidine hydrochloride .1 mg/1 60687-462-21 ANDA 2019-11-01
St. Mary's Medi oral benzonatate 100 mg/1 60760-700-30 ANDA 2019-10-25
Sandoz Inc subcutaneous pegfilgrastim-bmez 6 mg/.6mL 61314-866-01 BLA 2019-11-04
Theratechnologi subcutaneous tesamorelin 62064-241-30 NDA 2019-11-04
Alembic Pharmac topical clobetasol propionate .5 mg/mL 62332-486-25, 62332-486-50 ANDA 2019-10-24
Sun Pharmaceuti subcutaneous ganirelix acetate 250 ug/.5mL 62756-072-40 ANDA 2019-11-07
Alembic Pharmac topical desonide .5 mg/g 62332-485-15, 62332-485-60 ANDA 2019-10-24
ANI Pharmaceuti oral omega-3-acid ethyl esters 900 mg/1 62559-410-12 ANDA 2019-11-04
Vivimed Labs Li oral donepezil hydrochloride 5 mg/1 62980-907-07, 62980-907-04, 62980-907-05 ANDA 2019-11-05
Vivimed Labs Li oral donepezil hydrochloride 10 mg/1 62980-908-04, 62980-908-07, 62980-908-05 ANDA 2019-11-05
Sun Pharmaceuti oral erlotinib 25 mg/1 63304-095-30, 63304-095-11 ANDA 2019-11-05
Sun Pharmaceuti oral erlotinib 100 mg/1 63304-096-11, 63304-096-30 ANDA 2019-11-05
Sun Pharmaceuti oral erlotinib 150 mg/1 63304-135-11, 63304-135-30 ANDA 2019-11-05
Darby Dental Su dental sodium fluoride 2.72 g/100g 66467-8003-2 UNAPPROVED DRUG OTHER 2019-10-29
RedPharm Drug, oral metformin hydrochloride 500 mg/1 67296-1701-3 ANDA 2019-11-01
RedPharm Drug, oral clindamycin hydrochloride 150 mg/1 67296-1702-3, 67296-1702-4 ANDA 2019-11-01
Darby Dental Su dental sodium fluoride 2.72 g/100g 66467-8004-2 UNAPPROVED DRUG OTHER 2019-10-29
Darby Dental Su dental sodium fluoride 2.72 g/100g 66467-8005-2 UNAPPROVED DRUG OTHER 2019-10-29
RedPharm Drug, oral prednisone 5 mg/1 67296-1704-2 ANDA 2019-11-01
RedPharm Drug, oral hydrocodone bitartrate and acetaminophen 7.5 mg/1, 325 mg/1 67296-1705-6, 67296-1705-3 ANDA 2019-11-01
RedPharm Drug, oral tizanidine 4 mg/1 67296-1192-1 ANDA 2019-10-29
RedPharm Drug, oral gabapentin 300 mg/1 67296-1710-6 ANDA 2019-11-01
Lupin Pharmaceu norethindrone acetate and ethinyl estradiol 68180-866-73 ANDA 2019-11-07
Amneal Pharmace oral erythromycin 400 mg/5mL 69238-1504-2 ANDA 2019-11-04
Yiling Pharmace oral buspirone hydrochloride 30 mg/1 69117-0043-1, 69117-0043-2 ANDA 2019-10-30
Yiling Pharmace oral buspirone hydrochloride 10 mg/1 69117-0041-1, 69117-0041-2 ANDA 2019-10-30
Amneal Pharmace oral sirolimus 1 mg/mL 69238-1594-3 ANDA 2019-10-25
Yiling Pharmace oral buspirone hydrochloride 15 mg/1 69117-0042-4, 69117-0042-2, 69117-0042-3, 69117-0042-1 ANDA 2019-10-30
Yiling Pharmace oral buspirone hydrochloride 5 mg/1 69117-0040-2, 69117-0040-1 ANDA 2019-10-30
AMICI PHARMACEU oral propranolol hydrochloride 80 mg/1 69292-538-50, 69292-538-01, 69292-538-10 ANDA 2019-10-31
AMICI PHARMACEU oral propranolol hydrochloride 10 mg/1 69292-530-10, 69292-530-01 ANDA 2019-10-31
Amneal Pharmace oral erythromycin 200 mg/5mL 69238-1503-1 ANDA 2019-11-04
AMICI PHARMACEU oral propranolol hydrochloride 60 mg/1 69292-536-01, 69292-536-10 ANDA 2019-10-31
AMICI PHARMACEU oral propranolol hydrochloride 20 mg/1 69292-532-10, 69292-532-01 ANDA 2019-10-31
AMICI PHARMACEU oral propranolol hydrochloride 40 mg/1 69292-534-01, 69292-534-10 ANDA 2019-10-31
Amneal Pharmace intravenous ephedrine sulfate 50 mg/mL 70121-1637-7, 70121-1637-5 ANDA 2019-10-23
Covis Pharma intramuscular, intravenous digoxin 250 ug/mL 70515-261-10 NDA 2019-10-29
Covis Pharma intramuscular, intravenous digoxin 100 ug/mL 70515-263-10 NDA 2019-10-29
REMEDYREPACK IN oral cabergoline .5 mg/1 70518-2379-0 ANDA 2019-10-23
REMEDYREPACK IN oral rifampin 300 mg/1 70518-2404-0 ANDA 2019-11-05
REMEDYREPACK IN oral oxcarbazepine 600 mg/1 70518-2377-0 ANDA 2019-10-23
SunGen Pharma L intramuscular dicyclomine hydrochloride 20 mg/2mL 70625-103-05 ANDA 2019-11-04
REMEDYREPACK IN oral paroxetine hydrochloride hemihydrate 20 mg/1 70518-2387-0 ANDA 2019-10-24
REMEDYREPACK IN oral carvedilol 25 mg/1 70518-2389-0 ANDA 2019-10-25
REMEDYREPACK IN topical triamcinolone acetonide 1 mg/g 70518-2403-0 ANDA 2019-11-04
REMEDYREPACK IN intravenous, subcutaneous insulin lispro 100 U/mL 70518-2399-0 NDA 2019-10-30
REMEDYREPACK IN oral warfarin 3 mg/1 70518-2380-0 ANDA 2019-10-23
REMEDYREPACK IN oral warfarin 2 mg/1 70518-2381-0 ANDA 2019-10-23
REMEDYREPACK IN oral warfarin 1 mg/1 70518-2383-0 ANDA 2019-10-24
REMEDYREPACK IN oral topiramate 200 mg/1 70518-2391-0 ANDA 2019-10-26
REMEDYREPACK IN topical triamcinolone acetonide 1 mg/g 70518-2393-0 ANDA 2019-10-28
REMEDYREPACK IN oral warfarin 6 mg/1 70518-2394-0 ANDA 2019-10-28
REMEDYREPACK IN oral olanzapine 15 mg/1 70518-2375-0 ANDA 2019-10-23
REMEDYREPACK IN oral paroxetine hydrochloride hemihydrate 10 mg/1 70518-2376-0 ANDA 2019-10-23
REMEDYREPACK IN oral spironolactone 50 mg/1 70518-2386-0 ANDA 2019-10-24
Denton Pharma, oral ramipril 5 mg/1 70934-460-30 ANDA 2019-10-29
SunGen Pharma L topical lidocaine 50 mg/g 70625-400-01 ANDA 2019-10-23
REMEDYREPACK IN oral ziprasidone hydrochloride 60 mg/1 70518-2374-0 ANDA 2019-10-22
REMEDYREPACK IN oral dutasteride .5 mg/1 70518-2378-0 ANDA 2019-10-23
REMEDYREPACK IN oral warfarin 5 mg/1 70518-2382-0 ANDA 2019-10-23
REMEDYREPACK IN ophthalmic ciprofloxacin 3 mg/mL 70518-2390-0 ANDA 2019-10-25
SunGen Pharma, intravenous fosaprepitant dimeglumine 150 mg/5mL 70625-300-01 ANDA 2019-11-05
REMEDYREPACK IN oral spironolactone 100 mg/1 70518-2384-0 ANDA 2019-10-24
REMEDYREPACK IN oral spironolactone 25 mg/1 70518-2385-0 ANDA 2019-10-24
REMEDYREPACK IN oral oxybutynin chloride 10 mg/1 70518-2388-0 ANDA 2019-10-25
REMEDYREPACK IN oral warfarin 4 mg/1 70518-2395-0 ANDA 2019-10-28
REMEDYREPACK IN intravenous, subcutaneous insulin lispro 100 [iU]/mL 70518-2398-0 NDA AUTHORIZED GENERIC 2019-10-30
REMEDYREPACK IN vaginal metronidazole 7.5 mg/g 70518-2400-0 NDA 2019-11-01
REMEDYREPACK IN oral clonazepam .5 mg/1 70518-2392-0 ANDA 2019-10-26
REMEDYREPACK IN oral oseltamivir phosphate 75 mg/1 70518-2397-0 ANDA 2019-10-30
REMEDYREPACK IN oral doxepin hydrochloride 10 mg/1 70518-2401-0 ANDA 2019-11-03
Meitheal Pharma intravenous meropenem 1 g/1 71288-015-31 ANDA 2019-11-04
Denton Pharma, oral lisinopril 40 mg/1 70934-456-30 ANDA 2019-10-25
Meitheal Pharma intravenous meropenem 500 mg/1 71288-014-21 ANDA 2019-11-04
Eton Pharmaceut intravenous phenylephrine hydrochloride .1 mg/mL 71863-202-06 NDA 2019-11-01
Meitheal Pharma intravenous cisatracurium besylate 10 mg/5mL 71288-712-06 ANDA 2019-10-31
Meitheal Pharma intravenous cisatracurium besylate 200 mg/20mL 71288-713-21 ANDA 2019-10-31
Meitheal Pharma intravenous cisatracurium besylate 20 mg/10mL 71288-714-11 ANDA 2019-10-31
Aleor Dermaceut topical clobetasol propionate .05 g/mL 71589-003-59, 71589-003-12 ANDA 2019-10-31
Aleor Dermaceut topical desonide .5 mg/g 71589-005-60, 71589-005-15 ANDA 2019-11-02
Aleor Dermaceut topical clobetasol propionate .5 mg/mL 71589-004-25, 71589-004-50 ANDA 2019-11-02
CELLTRION USA, oral capecitabine 500 mg/1 72606-555-01 ANDA 2019-11-06
CELLTRION USA, oral imatinib mesylate 100 mg/1 72606-556-01 ANDA 2019-11-06
CELLTRION USA, oral capecitabine 150 mg/1 72606-554-01 ANDA 2019-11-06
CELLTRION USA, oral imatinib mesylate 400 mg/1 72606-557-01 ANDA 2019-11-06
GE Healthcare intravenous gadoterate meglumine 376.9 mg/mL 0407-2943-02, 0407-2943-05, 0407-2943-01 ANDA 2019-11-01
Decatur Memoria intravenous ammonia n 13 37.5 mCi/mL 73410-001-01 ANDA 2019-11-06
Hospira, Inc. intravenous doxercalciferol 2 ug/mL 0409-1330-01 NDA 2019-10-24
Decatur Memoria intravenous fludeoxyglucose f 18 20 mCi/mL 73410-003-01 ANDA 2019-11-06
Upstream Pharma lidocaine 5% ointment and menthol 10% topical liquid 73272-300-01 ANDA 2019-11-01
Decatur Memoria intravenous choline c 11 4 mCi/mL 73410-004-01 ANDA 2019-11-06
American Regent intra-articular, intralesional, intramuscular betamethasone sodium phosphate and betamethasone acetate 3 mg/mL, 3 mg/mL 0517-0791-01 ANDA 2019-11-01
American Regent intra-articular, intralesional, intramuscular betamethasone sodium phosphate and betamethasone acetate 3 mg/mL, 3 mg/mL 0517-0799-01 ANDA 2019-11-01
Lannett Company oral clobazam 20 mg/1 0527-1682-01 ANDA 2019-10-30
Lannett Company oral clobazam 10 mg/1 0527-1681-01 ANDA 2019-10-30
Sandoz Inc rectal mesalamine 1000 mg/1 0781-7088-33 ANDA 2019-11-01
ICU Medical Inc intravenous sodium chloride and potassium chloride 9 g/1000mL, 1.49 g/1000mL 0990-7115-09 NDA 2019-11-01
ICU Medical Inc intravenous isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine 990 mg/100mL, 1500 mg/100mL, 1575 mg/100mL, 258 mg/100mL, 447 mg/100mL, 600 mg/100mL, 300 mg/100mL, 750 mg/100mL, 1490 mg/100mL, 1527 mg/100mL, 1050 mg/100mL, 1107 mg/100mL, 450 mg/100mL, 1083 mg/100mL, 795 mg/100mL, 405 mg/100mL, 750 mg/100mL 0990-7171-17 NDA 2019-11-01
ICU Medical Inc intravenous isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine 660 mg/100mL, 1000 mg/100mL, 1050 mg/100mL, 172 mg/100mL, 298 mg/100mL, 400 mg/100mL, 200 mg/100mL, 500 mg/100mL, 993 mg/100mL, 1018 mg/100mL, 700 mg/100mL, 738 mg/100mL, 300 mg/100mL, 722 mg/100mL, 530 mg/100mL, 270 mg/100mL, 500 mg/100mL 0990-7172-17 NDA 2019-11-01
ICU Medical Inc intravenous isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine 760 mg/100mL, 1200 mg/100mL, 677 mg/100mL, 180 mg/100mL, 427 mg/100mL, 512 mg/100mL, 180 mg/100mL, 673 mg/100mL, 698 mg/100mL, 1227 mg/100mL, 527 mg/100mL, 820 mg/100mL, 385 mg/100mL, 312 mg/100mL, 812 mg/100mL, 495 mg/100mL, 70 mg/100mL, 44 mg/100mL 0990-4179-05 NDA 2019-11-01
NorthStar Rx LL oral omeprazole 10 mg/1 16714-714-01 ANDA 2019-10-25
Torrent Pharmac topical clobetasol propionate .5 mg/g 13668-603-01, 13668-603-02, 13668-603-04, 13668-603-05 ANDA 2019-10-25
Northstar RxLLC topical testosterone 20.25 mg/1.25g 16714-967-01 ANDA 2019-11-06
NorthStar Rx LL oral omeprazole 20 mg/1 16714-715-02, 16714-715-01, 16714-715-03 ANDA 2019-10-25
Northstar RxLLC topical testosterone 20.25 mg/1.25g 16714-968-02 ANDA 2019-11-06
NorthStar Rx LL oral omeprazole 40 mg/1 16714-123-03, 16714-123-02, 16714-123-01 ANDA 2019-10-25
Northstar RxLLC topical testosterone 40.5 mg/2.5g 16714-969-02 ANDA 2019-11-06
Macleods Pharma oral vardenafil hydrochloride 2.5 mg/1 33342-151-07, 33342-151-11, 33342-151-12 ANDA 2019-10-24
Macleods Pharma oral vardenafil hydrochloride 5 mg/1 33342-152-11, 33342-152-07, 33342-152-12 ANDA 2019-10-24
Macleods Pharma oral vardenafil hydrochloride 20 mg/1 33342-154-11, 33342-154-07, 33342-154-31 ANDA 2019-10-24
Macleods Pharma oral vardenafil hydrochloride 10 mg/1 33342-153-12, 33342-153-11, 33342-153-07 ANDA 2019-10-24
GlaxoSmithKline oral carvedilol phosphate 20 mg/1 0007-3385-13 NDA 2019-11-01
GlaxoSmithKline oral carvedilol phosphate 80 mg/1 0007-3388-13 NDA 2019-11-01
GlaxoSmithKline oral carvedilol phosphate 10 mg/1 0007-3383-13 NDA 2019-11-01
GlaxoSmithKline oral carvedilol phosphate 40 mg/1 0007-3387-13 NDA 2019-11-01
Acella Pharmace topical ciclopirox 80 mg/mL 42192-715-06 ANDA 2019-11-04
Chemi Pharma LL intravenous decitabine 50 mg/20mL 42737-110-01 ANDA 2019-10-31
Dr.Reddy's Labo intravenous bortexomib 3.5 mg/1 43598-865-60 NDA 2019-11-01
Amerigen Pharma oral ranolazine 500 mg/1 43975-290-06, 43975-290-50 ANDA 2019-10-29
BioComp Pharma, oral prednisolone sodium phosphate 25 mg/5mL 44523-182-08 ANDA 2019-10-28
Actavis Pharma, oral metoprolol succinate 25 mg/1 45963-709-96, 45963-709-11 ANDA 2019-10-23
Actavis Pharma, oral metoprolol succinate 200 mg/1 45963-678-11 ANDA 2019-10-23
Amerigen Pharma oral ranolazine 1 g/1 43975-289-06, 43975-289-50 ANDA 2019-10-29
Actavis Pharma, oral metoprolol succinate 100 mg/1 45963-677-96 ANDA 2019-10-23

List of new API DMFs (drug master files) from FDA which is updated quarterly

Company Submit Date Subject
LUPIN LTD 2019-09-30 RALTEGRAVIR POTASSIUM CRYSTALLINE
GLAND PHARMA LT 2019-09-30 ETOMIDATE
AUROBINDO PHARM 2019-09-26 DEFERASIROX
MAITHRI DRUGS P 2019-09-30 NITROFURANTOIN ANHYDROUS USP
ZHEJIANG JIUZHO 2019-09-30 SITAGLIPTIN PHOSPHATE
MAITHRI DRUGS P 2019-09-30 VARENICLINE TARTRATE
METROCHEM API P 2019-09-23 Oxiconazole Nitrate
DIPHARMA FRANCI 2019-09-30 CHENODEOXYCHOLIC ACID
BEIJING SJAR TE 2019-09-16 TOFACITINIB CITRATE
SYMBIOTEC PHARM 2019-09-11 ESTRADIOL HEMIHYDRATE USP
SHANGHAI DESANO 2019-09-16 LOPINAVIR HYDRATE
ALEMBIC PHARMAC 2019-09-30 Sorafenib Tosylate (Form-I)
SUVEN LIFE SCIE 2019-09-20 CHLOROQUINE PHOSPHATE USP
FORMOSA LABORAT 2019-09-12 GADOTERATE MEGLUMINE
CIPLA LTD 2019-09-30 SORAFENIB TOSYLATE 3
HARMAN FINOCHEM 2019-09-24 GLYCOPYRROLATE TOSYLATE
R L FINE CHEM P 2019-08-30 CARBINOXAMINE MALEATE
APEX HEALTHCARE 2019-09-21 LIDOCAINE USP
WISDOM PHARMACE 2019-09-09 LACOSAMIDE
CKD BIO CORP 2019-08-28 EVEROLIMUS, NON-STERILE API
SINOPEP-ALLSINO 2019-09-19 LIRAGLUTIDE
CTX LIFESCIENCE 2019-08-28 OXCARBAZEPINE USP
ZHEJIANG CHARIO 2019-09-02 FAMCICLOVIR
AURORE LIFE SCI 2019-08-26 LEVETIRACETAM USP
MACLEODS PHARMA 2019-09-27 VARENICLINE TARTRATE
GVK BIOSCIENCES 2019-09-13 PENTOSAN POLYSULFATE SODIUM
MSN LIFE SCIENC 2019-09-09 PANTOPRAZOLE SODIUM USP
BRIGHTGENE BIO- 2019-09-29 CASPOFUNGIN ACETATE (DKB)
HEC PHARM CO LT 2019-08-31 APREMILAST NON-STERILE BULK DRUG SUBSTANCE
AMOLI ORGANICS 2019-09-05 DIMETHYL FUMARATE
VIWIT PHARMACEU 2019-09-20 VILDAGLIPTIN
SRINI PHARMACEU 2019-08-29 LABETALOL HYDROCHLORIDE USP
NINGBO MENOVO P 2019-09-30 APIXABAN
JIANGSU HANSOH 2019-09-05 FULVESTRANT USP, NON-STERILE BULK DRUG SUBSTANCE
USV PRIVATE LTD 2019-08-31 SUGAMMADEX SODIUM
SUN PHARMACEUTI 2019-09-30 CANAGLIFLOZIN CRYSTALLINE
MSN LIFE SCIENC 2019-09-11 PLECANATIDE
SUN PHARMACEUTI 2019-09-19 IXAZOMIB CITRATE
GRILLO ZINKOXID 2019-09-16 ZINC OXIDE
CLEAVE THERAPEU 2019-09-06 CB 5339 DRUG SUBSTANCE
IRE (INSTITUT N 2019-08-29 SODIUM MOLYBDATE MO 99 FISSION
CLEAVE THERAPEU 2019-09-06 CB-5339 DRUG PRODUCT
NIPPON SUISAN K 2019-09-16 EPA-E NISSUI KASHIMA
ZHEJIANG STARRY 2019-09-10 HYDROXYACETYL IODIDE
YUNG SHIN PHARM 2019-09-27 CINACALCET HYDROCHLORIDE (YUNG SHIN)
US ARMY MEDICAL 2019-08-29 NF54 PLASMODIUM FALCIPARUM HUMAN MALARIA CHALLENGE
SCINOPHARM TAIW 2019-09-06 PEMETREXED DISODIUM USP
ASKLEPIOS BIOPH 2019-09-10 RECOMBINANT ADENO-ASSOCIATED VIRUS (RAAV)
ENALTEC LABS PR 2019-08-30 FLUPHENAZINE HYDROCHLORIDE USP
YUNG SHIN PHARM 2019-09-24 VORICONAZOLE "YUNG SHIN"
JOHNSON MATTHEY 2019-09-06 ABF 7131
THE UNIVERSITY 2019-09-19 68 GA GALLIUM CHLORIDE
REALI TIDE BIOL 2019-08-27 LEUPROLIDE ACETATE
ZHEJIANG AUSUN 2019-08-31 RAMELTEON
AMPHASTAR NANJI 2019-08-22 BUDESONIDE USP
HANGZHOU ZHONGM 2019-09-25 DAPTOMYCIN
ZHEJIANG HUAHAI 2019-09-17 AZELAIC ACID
BIOPHORE INDIA 2019-09-10 GADOBUTROL MONOHYDRATE
SCI PHARMTECH I 2019-09-24 SODIUM VALPROATE
LAURUS LABS LTD 2019-08-30 RITONAVIR USP
SUN PHARMACEUTI 2019-09-26 BOSENTAN MONOHYDRATE
CHATTEM CHEMICA 2019-09-27 DIHYDROCODEINE BITARTRATE USP
YABAO PHARMACEU 2019-09-27 TOFACITINIB CITRATE

Abriged, not to be used by medical professionals, updated daily from the FDA website

Company Drug Reason NDCs Date Lot Quantity
Taro Pharmaceut Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1 Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. 51672-2130-1, 51672-2130-8 20191106 Lot #: J871033187, Exp 9/20 5,190 bottles
Taro Pharmaceut Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9 Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. 51672-1385-8, 51672-1385-9 20191106 Lot #: J78402968, J784129698, Exp 9/19; K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19; A887230568, A887330568, A887430568, Exp 12/19; B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20; D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20; E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20; F865131834, Exp 5/20; G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20; H865232436, H865332436, H870832436, Exp 7/20; I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20; J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20; L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20; A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20; B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21 639,325 bottles
Nephron Pharmac PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10. Incorrect labeling: Incorrect or missing lot and/or exp date 20191106 Lots: SU9079A, SU9079B, Exp 4/5/2020 19,390 syringes
Mylan Pharmaceu Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93 Failed Dissolution Specification: Low out of specification dissolution results. 0378-5186-93, 0378-5185-93 20191106 Lot #: 3089793, Exp. Date September 2020 4,272 bottles
Taro Pharmaceut Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04 Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. 67091-321-04 20191106 Lot #: A972834374, Exp 12/20 5,280 bottles
Sandoz Inc Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06 Labeling: Incorrect or missing package insert. 61314-630-06 20191106 Lot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp. 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021. 346,929 bottles
Sandoz Inc Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25. Labeling: Incorrect or missing package insert. 61314-672-25 20191106 Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020 76,644 bottles
AuroMedics Phar Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79 CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty. 20191106 Lot #: NBSB19001DA3, Exp. date 02/2021 69696 bottles
Glenmark Pharma Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430. Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. 68462-711-88, 68462-711-71 20191106 Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020 216,840 cartons
Apotex Inc. Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8 Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. 60505-2578-9, 60505-2671-7, 60505-2580-3, 60505-2580-0, 60505-2580-7, 60505-2580-5, 60505-2580-9, 60505-2580-8, 60505-2671-8, 60505-2671-9, 60505-2579-5, 60505-2579-0, 60505-2579-7, 60505-2578-3, 60505-2578-0, 60505-2579-3, 60505-2578-7, 60505-2578-5, 60505-2671-0, 60505-2578-8, 60505-2671-3, 60505-2671-5, 60505-2579-9, 60505-2579-8 20191106 Lot: RC5439 Exp. 03/2022 1968 bottles
AVKARE Inc. AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API 42291-735-50, 42291-736-50, 3422917355 20191106 Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021 7293 bottles
Nephron Pharmac PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25 GMP Deviations: potential glass contamination 20191030 Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019 1370 bags
Innoveix Pharma Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 Lack of Sterility Assurance. 20191106 Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20 3905 vials
Innoveix Pharma Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 Lack of Sterility Assurance. 20191106 Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20 413 vials
Nephron Pharmac del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10 Lack of Assurance of Sterility; bags have potential to leak 20191030 Lots: NC9048A Exp. 10/14/2019; NC9048B Exp. 10/14/2019; NC9049A Exp. 10/16/2019; NC9049B Exp. 10/16/2019; NC9051A Exp. 10/21/2019; NC9051B Exp. 10/21/2019; NC9052A Exp. 10/22/2019; NC9052B Exp. 10/22/2019; NC9053A Exp. 10/23/2019; NC9053B Exp. 10/23/2019; NC9054A Exp. 10/28/2019; NC9054B Exp. 10/28/2019; NC9055A Exp. 10/30/2019; NC9056B Exp. 11/04/2019 1047 bags
Aurobindo Pharm Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01 Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. 13107-070-50, 13107-070-99, 13107-068-99, 13107-074-25, 13107-073-50, 13107-074-99, 13107-072-99, 13107-069-99, 13107-069-50, 13107-068-25, 13107-068-01, 13107-068-05, 13107-070-01, 13107-070-05, 13107-072-25, 13107-073-25, 13107-074-01, 13107-070-25, 13107-073-01, 13107-072-05, 13107-073-05, 13107-072-01, 13107-071-25, 13107-071-01, 13107-071-05, 13107-074-05, 13107-069-25, 13107-073-99, 13107-071-99, 13107-069-05, 13107-069-01, 13107-074-50, 13107-068-50, 13107-072-50, 13107-071-50 20191023 Batch 07319032A1, Exp 02/2021 11,129 100-count bottles
Ingenus Pharmac Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839 Crystallization: Presence of particulate matter identified as API crystallization 50742-464-50 20191023 Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020 16485 vials
Taro Pharmaceut Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8 Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. 51672-2130-1, 51672-2130-8 20191106 Lot #: E875131667, E875231667, Exp 4/20; J871033189, J871133189, Exp 9/20; A972934375, A973034375, Exp 12/20 182,986 bottles
Taro Pharmaceut Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8 Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. 51672-1385-8, 51672-1385-9 20191106 Lot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21 138,886 bottles
FITOTERAPIA USA Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL), Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028 Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. 20191106 Lot #: ZD-160-18, Exp. 09-07-2019; ZD-078-19 Exp. 27-04-2020 19000 bottles
Innoveix Pharma Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 Lack of Sterility Assurance. 20191106 Lots: INX 50 Exp. 5/1/20 290 vials
Atlas Pharmaceu Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50. Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source. 20191023 Lot #: S-60162, BUD 10/12/2019; S-60176, BUD 11/2/2019; S-60187, BUD 11/11/2019; S-60189, BUD 11/16/2019; S-60190, BUD 11/16/2019; S-60222, BUD 01/20/2020 1646 vials
Macleods Pharma Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07 Superpotent 33342-056-10, 33342-054-15, 33342-054-07, 33342-054-12, 33342-054-10, 33342-055-10, 33342-056-07, 33342-055-12, 33342-056-12, 33342-055-07, 33342-055-15, 33342-056-15 20191023 Lot # BPF901A, exp. date 12/2021 31,968 bottles
Arbor Pharmaceu Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01 Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials 52536-625-01, 52536-625-10 20191106 lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021 67934 units
Nephron Pharmac PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20 GMP Deviations: potential glass contamination 20191030 Lot: FR9002A Exp. 12/12/2019 615 bags
Innoveix Pharma Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 Lack of Sterility Assurance. 20191106 Lots: SER 925 Exp. 11/4/19; SER 930 Exp. 11/18/19; SER 935 Exp. 2/21/20; SER 400 Exp. 4/1/20; SER 405 Exp. 5/11/20; SER 410 Exp. 7/15/20 1747 vials
Nephron Pharmac PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25 GMP Deviations: potential glass contamination 20191030 Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019 1855 bags
Avella of Deer Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20 Lack of sterility assurance. 20191030 Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019 808 droptainers
Sandoz Inc Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina. Labeling: Incorrect or missing package insert. 0781-6206-93, 0781-6206-75 20191106 Lot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021. 346,929 bottles
AVKARE Inc. AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API 42291-735-50, 42291-736-50, 3422917365 20191106 Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020 1351 bottles
Spectrum Labora Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 CGMP Deviations: Received notice from supplier that there is potential glass contamination. 20191023 Lot # 1HE0899, 1IB0005, Exp 02/28/2023 29.1 grams
KVK-Tech, Inc. Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50. Presence of Foreign Substance; Fiber particles. 20191023 Batch # 15315A, Exp. 02/2021 384 bottles
Jubilant Cadist Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90 CGMP Deviation: Presence of dark brown discoloration on edges of tablets. 59746-284-90, 59746-283-03, 59746-283-01, 59746-284-30, 59746-283-05, 59746-284-10, 59746-284-01, 59746-283-30, 59746-284-05, 59746-284-03, 59746-283-90, 59746-283-10 20191023 Lot # PA218P008, PA218P009, Exp 04/2021 63,216 bottles
Nephron Pharmac Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10 Lack of Assurance of Sterility; bags have potential to leak 20191030 Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019 162 bags

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