Latest News

4 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
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 Miami US 2019-10-18 Drug Quality Assurance VAI
DPT Laboratories, Lt San Antonio US 2019-10-23 Drug Quality Assurance NAI

WIZMED searches for the latest public 483s weekly.

MFG Country Date Link
Aurobindo Pharma Ltd. Unit 8 India 2019-10-25
Aurobindo Pharma Ltd. Unit 5 India 2019-10-28

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

Company Issue Date Office Link

Monitor latest FDA approvals

MFG Route Drug Strength NDCs Type Approval Date PI Labels
DIRECT RX oral lansoprazole 30 mg/1 72189-062-90 ANDA 2019-11-20
DIRECT RX oral valacyclovir hydrochloride 1 g/1 72189-037-21 ANDA 2019-11-18
Civica, Inc. intravenous labetalol hydrochloride 5 mg/mL 72572-350-01 ANDA 2019-11-21
Beigene Usa, In oral zanubrutinib 80 mg/1 72579-011-01, 72579-011-02 NDA 2019-11-18
Civica, Inc. intramuscular, intravenous prochlorperazine edisylate 5 mg/mL 72572-580-25 ANDA 2019-11-18
Civica, Inc. intramuscular, intravenous ondansetron 2 mg/mL 72572-520-25 ANDA 2019-11-18
Lannett Company oral clarithromycin 250 mg/1 0527-1931-06 ANDA 2019-11-23
Lannett Company oral clarithromycin 500 mg/1 0527-1932-06 ANDA 2019-11-23
ICU Medical Inc intravenous dextrose monohydrate 10 g/100mL 0990-7938-19 NDA 2019-11-20
ICU Medical Inc irrigation acetic acid 250 mg/100mL 0990-6143-09 NDA 2019-11-25
Sun Pharmaceuti oral isotretinoin 20 mg/1 10631-004-31 NDA 2019-11-20
Sun Pharmaceuti oral isotretinoin 8 mg/1 10631-002-31 NDA 2019-11-20
Sun Pharmaceuti oral isotretinoin 16 mg/1 10631-003-31 NDA 2019-11-20
Sun Pharmaceuti oral isotretinoin 32 mg/1 10631-007-31 NDA 2019-11-20
Sun Pharmaceuti oral isotretinoin 28 mg/1 10631-006-31 NDA 2019-11-20
Sun Pharmaceuti oral isotretinoin 24 mg/1 10631-005-31 NDA 2019-11-20
Encube Ethicals topical clobetasol propionate ointment usp, 0.05% .5 mg/g 21922-017-07, 21922-017-04, 21922-017-05, 21922-017-06 ANDA 2019-11-18
Leucadia Pharma intravenous ganciclovir 500 mg/10mL 24201-500-25 ANDA 2019-11-20
X-GEN Pharmaceu intramuscular, intravenous, subcutaneous folic acid 5 mg/mL 39822-1100-1 ANDA 2019-11-17
Alembic Pharmac oral deferasirox 90 mg/1 46708-410-30, 46708-410-91 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 360 mg/1 46708-412-91, 46708-412-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 125 mg/1 46708-324-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 250 mg/1 46708-325-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 500 mg/1 46708-326-30 ANDA 2019-11-21
Pharmacia and U intramuscular, intravenous clindamycin phosphate 150 mg/mL 0009-3051-02 NDA 2019-11-18
Pharmacia and U intramuscular, intravenous clindamycin phosphate 150 mg/mL 0009-4073-04 NDA 2019-11-18
Pharmacia and U intramuscular, intravenous clindamycin phosphate 150 mg/mL 0009-5095-06 NDA 2019-11-18
General Injecta intramuscular, intravenous succinylcholine chloride 20 mg/mL 52584-097-01 ANDA 2019-11-21
Quality Care Pr oral nitrofurantoin (monohydrate/macrocrystals) 75 mg/1, 25 mg/1 55700-822-14 ANDA 2019-11-19
Quality Care Pr oral fluoxetine hydrochloride 40 mg/1 55700-821-30 ANDA 2019-11-22
Quality Care Pr oral bupropion hydrochloride 300 mg/1 55700-820-30 ANDA 2019-11-22
Clinical Soluti oral tamsulosin hydrochloride .4 mg/1 58118-0598-8 ANDA 2019-11-19
Clinical Soluti oral levofloxacin 500 mg/1 58118-1022-8 ANDA 2019-11-20
Clinical Soluti oral metoprolol tartrate 25 mg/1 58118-1062-8 ANDA 2019-11-19
Method Pharmace oral labetalol hydrochloride 200 mg/1 58657-603-50, 58657-603-01, 58657-603-10 ANDA 2019-11-22
Method Pharmace oral labetalol hydrochloride 300 mg/1 58657-604-10, 58657-604-50, 58657-604-01 ANDA 2019-11-22
Method Pharmace oral labetalol hydrochloride 100 mg/1 58657-602-50, 58657-602-10, 58657-602-01 ANDA 2019-11-22
Alembic Pharmac oral deferasirox 90 mg/1 62332-410-91, 62332-410-30 ANDA 2019-11-21
Direct_Rx oral diazepam 5 mg/1 61919-409-02 ANDA 2019-11-18
Alembic Pharmac oral deferasirox 250 mg/1 62332-325-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 500 mg/1 62332-326-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 360 mg/1 62332-412-91, 62332-412-30 ANDA 2019-11-21
Alembic Pharmac oral deferasirox 125 mg/1 62332-324-30 ANDA 2019-11-21
Prasco Laborato oral nilutamide 150 mg/1 66993-212-38 NDA AUTHORIZED GENERIC 2019-11-22
Ascend Laborato oral deferasirox 250 mg/1 67877-550-30 ANDA 2019-11-22
BluePoint Labor intravenous fosaprepitant 150 mg/5mL 68001-421-22 ANDA 2019-11-20
Mylan Instituti intramuscular, intravenous, subcutaneous naloxone hydrochloride .4 mg/mL 67457-987-10 ANDA 2019-11-20
Ascend Laborato oral deferasirox 125 mg/1 67877-549-30 ANDA 2019-11-22
Ascend Laborato oral deferasirox 500 mg/1 67877-551-30 ANDA 2019-11-22
Gland Pharma Li intravenous irinotecan hydrochloide 20 mg/mL 68083-381-01 ANDA 2019-11-18
Gland Pharma Li intravenous irinotecan hydrochloride 20 mg/mL 68083-382-01 ANDA 2019-11-18
MSN LABORATORIE oral deferasirox 90 mg/1 69539-073-99, 69539-073-30 ANDA 2019-11-20
MSN LABORATORIE oral deferasirox 125 mg/1 69539-021-99, 69539-021-90, 69539-021-30 ANDA 2019-11-20
MSN LABORATORIE oral deferasirox 250 mg/1 69539-022-30, 69539-022-90, 69539-022-99 ANDA 2019-11-20
MSN LABORATORIE oral deferasirox 500 mg/1 69539-023-90, 69539-023-05, 69539-023-30 ANDA 2019-11-20
MSN LABORATORIE oral deferasirox 360 mg/1 69539-075-30, 69539-075-99 ANDA 2019-11-20
REMEDYREPACK IN oral propranolol hydrochloride 80 mg/1 70518-2444-0 ANDA 2019-11-22
REMEDYREPACK IN oral lorazepam 1 mg/1 70518-2442-0 ANDA 2019-11-21
Cadila Healthca oral isosorbide dinitrate 5 mg/1 70771-1501-1, 70771-1501-0 ANDA 2019-11-25
Cadila Healthca oral isosorbide dinitrate 10 mg/1 70771-1502-1, 70771-1502-0 ANDA 2019-11-25
Cadila Healthca oral isosorbide dinitrate 30 mg/1 70771-1504-0, 70771-1504-1 ANDA 2019-11-25
REMEDYREPACK IN oral ropinirole .5 mg/1 70518-2439-0 ANDA 2019-11-20
REMEDYREPACK IN oral venlafaxine 37.5 mg/1 70518-2423-0 ANDA 2019-11-17
REMEDYREPACK IN oral propranolol hydrochloride 40 mg/1 70518-2429-0 ANDA 2019-11-18
REMEDYREPACK IN oral quetiapine fumarate 50 mg/1 70518-2424-0 NDA 2019-11-18
REMEDYREPACK IN oral lovastatin 40 mg/1 70518-2425-0 ANDA 2019-11-18
REMEDYREPACK IN oral naproxen 500 mg/1 70518-2428-0 ANDA 2019-11-18
REMEDYREPACK IN oral azithromycin 250 mg/1 70518-2433-0 ANDA 2019-11-19
REMEDYREPACK IN oral pioglitazone 45 mg/1 70518-2431-0 ANDA 2019-11-18
REMEDYREPACK IN oral diltiazem hydrochloride 60 mg/1 70518-2443-0 NDA AUTHORIZED GENERIC 2019-11-22
REMEDYREPACK IN oral empagliflozin 25 mg/1 70518-2447-0 NDA 2019-11-22
REMEDYREPACK IN oral ibuprofen 400 mg/1 70518-2432-0 ANDA 2019-11-18
REMEDYREPACK IN oral ibuprofen 400 mg/1 70518-2440-0 ANDA 2019-11-20
Cadila Healthca oral isosorbide dinitrate 20 mg/1 70771-1503-1, 70771-1503-0 ANDA 2019-11-25
REMEDYREPACK IN oral carbamazepine 100 mg/1 70518-2426-0 ANDA 2019-11-18
REMEDYREPACK IN oral penicillin v potasium 250 mg/1 70518-2441-0 ANDA 2019-11-21
Zydus Pharmaceu oral isosorbide dinitrate 20 mg/1 70710-1150-0, 70710-1150-1 ANDA 2019-11-25
Zydus Pharmaceu oral deferasirox 90 mg/1 70710-1275-3, 70710-1275-1 ANDA 2019-11-21
REMEDYREPACK IN oral atenolol and chlorthalidone 100 mg/1, 25 mg/1 70518-2446-0 ANDA 2019-11-22
REMEDYREPACK IN oral bupropion hydrochloride 75 mg/1 70518-2427-0 ANDA 2019-11-18
REMEDYREPACK IN oral escitalopram 5 mg/1 70518-2430-0 ANDA 2019-11-18
REMEDYREPACK IN oral enalapril maleate 2.5 mg/1 70518-2445-0 ANDA 2019-11-22
Zydus Pharmaceu oral isosorbide dinitrate 40 mg/1 70710-1152-1 ANDA 2019-11-25
Zydus Pharmaceu oral isosorbide dinitrate 5 mg/1 70710-1148-1, 70710-1148-0 ANDA 2019-11-25
Zydus Pharmaceu oral isosorbide dinitrate 10 mg/1 70710-1149-0, 70710-1149-1 ANDA 2019-11-25
Zydus Pharmaceu oral isosorbide dinitrate 30 mg/1 70710-1151-0, 70710-1151-1 ANDA 2019-11-25
Zydus Pharmaceu oral deferasirox 360 mg/1 70710-1277-1, 70710-1277-3 ANDA 2019-11-21
REMEDYREPACK IN oral mirabegron 50 mg/1 70518-2435-0 NDA 2019-11-19
REMEDYREPACK IN oral metoprolol tartrate 50 mg/1 70518-2437-0 ANDA 2019-11-19
REMEDYREPACK IN oral sertraline hydrochloride 100 mg/1 70518-2448-0 ANDA 2019-11-23
Cadila Healthca oral isosorbide dinitrate 40 mg/1 70771-1505-1 ANDA 2019-11-25
Zydus Pharmaceu topical desonide .5 mg/g 70710-1235-3, 70710-1235-1 ANDA 2019-11-25

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
ALEMBIC PHARMAC 2019-09-30 Sorafenib Tosylate (Form-I)
SUVEN LIFE SCIE 2019-09-20 CHLOROQUINE PHOSPHATE USP
CIPLA LTD 2019-09-30 SORAFENIB TOSYLATE 3
HARMAN FINOCHEM 2019-09-24 GLYCOPYRROLATE TOSYLATE
APEX HEALTHCARE 2019-09-21 LIDOCAINE USP
SINOPEP-ALLSINO 2019-09-19 LIRAGLUTIDE
MACLEODS PHARMA 2019-09-27 VARENICLINE TARTRATE
BRIGHTGENE BIO- 2019-09-29 CASPOFUNGIN ACETATE (DKB)
VIWIT PHARMACEU 2019-09-20 VILDAGLIPTIN
NINGBO MENOVO P 2019-09-30 APIXABAN
SUN PHARMACEUTI 2019-09-30 CANAGLIFLOZIN CRYSTALLINE
SUN PHARMACEUTI 2019-09-19 IXAZOMIB CITRATE
YUNG SHIN PHARM 2019-09-27 CINACALCET HYDROCHLORIDE (YUNG SHIN)
YUNG SHIN PHARM 2019-09-24 VORICONAZOLE "YUNG SHIN"
THE UNIVERSITY 2019-09-19 68 GA GALLIUM CHLORIDE
HANGZHOU ZHONGM 2019-09-25 DAPTOMYCIN
ZHEJIANG HUAHAI 2019-09-17 AZELAIC ACID
SCI PHARMTECH I 2019-09-24 SODIUM VALPROATE
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
8046255 Canada Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 20191120 Lot Numbers: 19-S00019, Exp. May: 2020 3 vials
8046255 Canada Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 20191120 Lot Numbers: 19-S00027, Exp. May: 2020 1 vial
Novitium Pharma Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10 CGMP Deviations: Presence of NDMA impurity detected in product. 20191120 all lots within expiry. 12312 bottles
8046255 Canada Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 20191120 Lot Numbers: 19-S00017, Exp. May: 2020 3 vials
8046255 Canada Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-402-79, 73069-402-75, 73069-402-84, 73069-402-66, 73069-402-87, 73069-402-33, 73069-402-86, 73069-402-58, 73069-402-59, 73069-402-56, 73069-402-57, 73069-402-54, 73069-402-55, 73069-402-52, 73069-402-53, 73069-402-72, 73069-402-51, 73069-402-71, 73069-402-18, 73069-402-19, 73069-402-38, 73069-402-39, 73069-402-76, 73069-402-77, 73069-402-12, 73069-402-13, 73069-402-36, 73069-402-11, 73069-402-16, 73069-402-17, 73069-402-14, 73069-402-15, 73069-402-65, 73069-402-64, 73069-402-31, 73069-402-34, 73069-402-89, 73069-402-88, 73069-402-35, 73069-402-85, 73069-402-73, 73069-402-74, 73069-402-68, 73069-402-81, 73069-402-69, 73069-402-83, 73069-402-82, 73069-402-49, 73069-402-48, 73069-402-37, 73069-402-41, 73069-402-43, 73069-402-42, 73069-402-45, 73069-402-44, 73069-402-47, 73069-402-46, 73069-402-63, 73069-402-62, 73069-402-61, 73069-402-78, 73069-402-67, 73069-402-32, 73069-402-29, 73069-402-28, 73069-402-27, 73069-402-26, 73069-402-25, 73069-402-24, 73069-402-23, 73069-402-22, 73069-402-21 20191120 Lot Numbers: 19-S00003, Exp. May: 2020 19 vials
8046255 Canada Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-375-76, 73069-375-84, 73069-375-75, 73069-375-33, 73069-375-85, 73069-375-32, 73069-375-82, 73069-375-83, 73069-375-88, 73069-375-81, 73069-375-86, 73069-375-87, 73069-375-48, 73069-375-49, 73069-375-46, 73069-375-47, 73069-375-44, 73069-375-45, 73069-375-42, 73069-375-43, 73069-375-69, 73069-375-41, 73069-375-61, 73069-375-62, 73069-375-63, 73069-375-28, 73069-375-29, 73069-375-66, 73069-375-67, 73069-375-24, 73069-375-25, 73069-375-26, 73069-375-27, 73069-375-21, 73069-375-22, 73069-375-23, 73069-375-89, 73069-375-78, 73069-375-74, 73069-375-73, 73069-375-72, 73069-375-68, 73069-375-71, 73069-375-59, 73069-375-58, 73069-375-51, 73069-375-64, 73069-375-53, 73069-375-52, 73069-375-55, 73069-375-54, 73069-375-57, 73069-375-56, 73069-375-15, 73069-375-14, 73069-375-17, 73069-375-16, 73069-375-11, 73069-375-39, 73069-375-13, 73069-375-12, 73069-375-37, 73069-375-36, 73069-375-35, 73069-375-34, 73069-375-19, 73069-375-18, 73069-375-31, 73069-375-65, 73069-375-77, 73069-375-38, 73069-375-79 20191120 Lot Numbers: 19-S00020, Exp. May: 2020 13 vials
Novitium Pharma Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20 CGMP Deviations: Presence of NDMA impurity detected in product. 20191120 all lots within expiry. 19560 bottles
Apotex Inc. Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 11822-6051-8, 11822-4727-3, 11822-6052-1, 11822-6052-2 20191120 All lots remaining within expiry. 215,387 bottles
Apotex Inc. Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 20191120 All lots remaining within expiry. 1,132,453 bottles
Golden State Me GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. CGMP Deviations: Presence of NDMA impurity detected in product. 51407-097-05, 51407-098-01 20191120 Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; GS025702, Exp. 10/31/2020; GS027272, Exp. 10/31/2020; GS027273, Exp. 05/31/2021.
8046255 Canada Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-249-86, 73069-249-87, 73069-249-84, 73069-249-67, 73069-249-82, 73069-249-53, 73069-249-81, 73069-249-73, 73069-249-64, 73069-249-57, 73069-249-88, 73069-249-61, 73069-249-68, 73069-249-62, 73069-249-89, 73069-249-63, 73069-249-83, 73069-249-21, 73069-249-22, 73069-249-23, 73069-249-24, 73069-249-25, 73069-249-26, 73069-249-27, 73069-249-42, 73069-249-43, 73069-249-66, 73069-249-41, 73069-249-46, 73069-249-47, 73069-249-44, 73069-249-45, 73069-249-85, 73069-249-69, 73069-249-72, 73069-249-52, 73069-249-79, 73069-249-74, 73069-249-55, 73069-249-54, 73069-249-48, 73069-249-19, 73069-249-18, 73069-249-49, 73069-249-11, 73069-249-51, 73069-249-13, 73069-249-12, 73069-249-15, 73069-249-14, 73069-249-17, 73069-249-16, 73069-249-33, 73069-249-32, 73069-249-31, 73069-249-56, 73069-249-37, 73069-249-36, 73069-249-35, 73069-249-34, 73069-249-77, 73069-249-76, 73069-249-39, 73069-249-38, 73069-249-59, 73069-249-58, 73069-249-71, 73069-249-28, 73069-249-29, 73069-249-65, 73069-249-75, 73069-249-78 20191120 Lot Numbers: 19-S00012, Exp. May: 2020 54 vials
8046255 Canada Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-100-65, 73069-100-73, 73069-100-61, 73069-100-79, 73069-100-88, 73069-100-77, 73069-100-81, 73069-100-82, 73069-100-83, 73069-100-84, 73069-100-85, 73069-100-86, 73069-100-87, 73069-100-75, 73069-100-28, 73069-100-29, 73069-100-26, 73069-100-27, 73069-100-24, 73069-100-25, 73069-100-22, 73069-100-23, 73069-100-21, 73069-100-68, 73069-100-69, 73069-100-48, 73069-100-49, 73069-100-44, 73069-100-45, 73069-100-46, 73069-100-47, 73069-100-66, 73069-100-41, 73069-100-42, 73069-100-43, 73069-100-72, 73069-100-59, 73069-100-67, 73069-100-58, 73069-100-71, 73069-100-62, 73069-100-89, 73069-100-63, 73069-100-78, 73069-100-55, 73069-100-39, 73069-100-38, 73069-100-54, 73069-100-64, 73069-100-31, 73069-100-76, 73069-100-33, 73069-100-32, 73069-100-35, 73069-100-34, 73069-100-37, 73069-100-36, 73069-100-13, 73069-100-12, 73069-100-11, 73069-100-74, 73069-100-17, 73069-100-16, 73069-100-15, 73069-100-14, 73069-100-57, 73069-100-56, 73069-100-19, 73069-100-18, 73069-100-53, 73069-100-52, 73069-100-51 20191120 Lot Numbers: 19-S00001, Exp. May: 2020 24 vials
Novitium Pharma Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40 CGMP Deviations: Presence of NDMA impurity detected in product. 20191120 all lots within expiry. 6660 bottles
Sato Pharmaceut Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603 Subpotent Drug 49873-803-01, 4987301603 20191120 Lot #: TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 2021. 21,864 units
Sato Pharmaceut Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946 Subpotent Drug 69842-288-01, 5042849946 20191120 Lot #: AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, AXCK, Exp. Date Nov 2021 39,504 units
8046255 Canada Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-270-65, 73069-270-69, 73069-270-72, 73069-270-86, 73069-270-87, 73069-270-84, 73069-270-85, 73069-270-82, 73069-270-83, 73069-270-81, 73069-270-23, 73069-270-62, 73069-270-88, 73069-270-89, 73069-270-61, 73069-270-55, 73069-270-51, 73069-270-54, 73069-270-22, 73069-270-21, 73069-270-48, 73069-270-49, 73069-270-24, 73069-270-25, 73069-270-26, 73069-270-27, 73069-270-28, 73069-270-29, 73069-270-66, 73069-270-41, 73069-270-46, 73069-270-47, 73069-270-44, 73069-270-45, 73069-270-53, 73069-270-79, 73069-270-52, 73069-270-63, 73069-270-42, 73069-270-74, 73069-270-43, 73069-270-68, 73069-270-78, 73069-270-75, 73069-270-19, 73069-270-18, 73069-270-67, 73069-270-73, 73069-270-64, 73069-270-11, 73069-270-57, 73069-270-13, 73069-270-12, 73069-270-15, 73069-270-14, 73069-270-17, 73069-270-16, 73069-270-33, 73069-270-32, 73069-270-31, 73069-270-56, 73069-270-37, 73069-270-36, 73069-270-35, 73069-270-34, 73069-270-77, 73069-270-76, 73069-270-39, 73069-270-38, 73069-270-59, 73069-270-58, 73069-270-71 20191120 Lot Numbers: 19-S00004, Exp. May: 2020 12 vials
8046255 Canada Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-164-15, 73069-164-14, 73069-164-17, 73069-164-16, 73069-164-11, 73069-164-76, 73069-164-13, 73069-164-12, 73069-164-37, 73069-164-36, 73069-164-35, 73069-164-34, 73069-164-19, 73069-164-18, 73069-164-31, 73069-164-64, 73069-164-77, 73069-164-69, 73069-164-65, 73069-164-73, 73069-164-39, 73069-164-83, 73069-164-38, 73069-164-85, 73069-164-82, 73069-164-68, 73069-164-81, 73069-164-86, 73069-164-87, 73069-164-48, 73069-164-49, 73069-164-46, 73069-164-47, 73069-164-44, 73069-164-45, 73069-164-42, 73069-164-43, 73069-164-41, 73069-164-72, 73069-164-61, 73069-164-33, 73069-164-63, 73069-164-28, 73069-164-29, 73069-164-66, 73069-164-67, 73069-164-24, 73069-164-25, 73069-164-26, 73069-164-27, 73069-164-62, 73069-164-21, 73069-164-22, 73069-164-23, 73069-164-84, 73069-164-75, 73069-164-88, 73069-164-71, 73069-164-32, 73069-164-89, 73069-164-79, 73069-164-78, 73069-164-59, 73069-164-58, 73069-164-74, 73069-164-51, 73069-164-53, 73069-164-52, 73069-164-55, 73069-164-54, 73069-164-57, 73069-164-56 20191120 Lot Numbers: 19-S00026, Exp. May: 2020 13 vials
8046255 Canada Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-102-52, 73069-102-73, 73069-102-77, 73069-102-85, 73069-102-79, 73069-102-59, 73069-102-58, 73069-102-64, 73069-102-88, 73069-102-72, 73069-102-51, 73069-102-53, 73069-102-33, 73069-102-55, 73069-102-54, 73069-102-57, 73069-102-56, 73069-102-15, 73069-102-14, 73069-102-17, 73069-102-16, 73069-102-11, 73069-102-76, 73069-102-13, 73069-102-12, 73069-102-37, 73069-102-36, 73069-102-35, 73069-102-34, 73069-102-19, 73069-102-18, 73069-102-31, 73069-102-65, 73069-102-39, 73069-102-71, 73069-102-32, 73069-102-38, 73069-102-75, 73069-102-89, 73069-102-68, 73069-102-81, 73069-102-69, 73069-102-74, 73069-102-87, 73069-102-82, 73069-102-83, 73069-102-78, 73069-102-86, 73069-102-84, 73069-102-48, 73069-102-49, 73069-102-46, 73069-102-47, 73069-102-44, 73069-102-45, 73069-102-42, 73069-102-43, 73069-102-41, 73069-102-61, 73069-102-62, 73069-102-63, 73069-102-28, 73069-102-29, 73069-102-66, 73069-102-67, 73069-102-24, 73069-102-25, 73069-102-26, 73069-102-27, 73069-102-21, 73069-102-22, 73069-102-23 20191120 Lot Numbers: 19-S00018, Exp. May: 2020 7 vials
8046255 Canada Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-037-59, 73069-037-36, 73069-037-88, 73069-037-86, 73069-037-71, 73069-037-45, 73069-037-29, 73069-037-28, 73069-037-49, 73069-037-48, 73069-037-44, 73069-037-23, 73069-037-22, 73069-037-47, 73069-037-46, 73069-037-27, 73069-037-26, 73069-037-25, 73069-037-24, 73069-037-67, 73069-037-66, 73069-037-37, 73069-037-64, 73069-037-63, 73069-037-62, 73069-037-61, 73069-037-81, 73069-037-41, 73069-037-83, 73069-037-82, 73069-037-85, 73069-037-72, 73069-037-69, 73069-037-68, 73069-037-87, 73069-037-84, 73069-037-43, 73069-037-42, 73069-037-75, 73069-037-74, 73069-037-53, 73069-037-73, 73069-037-65, 73069-037-16, 73069-037-17, 73069-037-14, 73069-037-15, 73069-037-12, 73069-037-13, 73069-037-11, 73069-037-31, 73069-037-32, 73069-037-33, 73069-037-34, 73069-037-35, 73069-037-18, 73069-037-19, 73069-037-52, 73069-037-38, 73069-037-76, 73069-037-51, 73069-037-56, 73069-037-57, 73069-037-54, 73069-037-39, 73069-037-77, 73069-037-58, 73069-037-55, 73069-037-78, 73069-037-79, 73069-037-21, 73069-037-89 20191120 Lot Numbers: 19-S00008, Exp. May: 2020 69 vials
8046255 Canada Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 20191120 Lot Numbers: 19-S00025, Exp. May: 2020 8 vials
Apotex Inc. Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 20191120 All lots remaining within expiry. 42,873 bottles
Apotex Inc. Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 0363-1030-09, 0363-1030-06, 0363-1030-07, 0363-1030-05, 0363-1030-02, 0363-1030-01 20191120 All lots remaining within expiry. 259,647 bottles
Apotex Inc. Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 11822-6107-4 20191120 All lots remaining within expiry. 31,968 bottles
8046255 Canada Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-443-46, 73069-443-47, 73069-443-44, 73069-443-45, 73069-443-42, 73069-443-43, 73069-443-41, 73069-443-77, 73069-443-61, 73069-443-62, 73069-443-63, 73069-443-64, 73069-443-65, 73069-443-48, 73069-443-49, 73069-443-24, 73069-443-25, 73069-443-26, 73069-443-27, 73069-443-21, 73069-443-22, 73069-443-23, 73069-443-55, 73069-443-28, 73069-443-29, 73069-443-75, 73069-443-54, 73069-443-88, 73069-443-89, 73069-443-82, 73069-443-83, 73069-443-81, 73069-443-68, 73069-443-87, 73069-443-72, 73069-443-85, 73069-443-59, 73069-443-66, 73069-443-58, 73069-443-73, 73069-443-71, 73069-443-84, 73069-443-51, 73069-443-53, 73069-443-52, 73069-443-19, 73069-443-18, 73069-443-57, 73069-443-56, 73069-443-15, 73069-443-14, 73069-443-17, 73069-443-16, 73069-443-11, 73069-443-76, 73069-443-13, 73069-443-12, 73069-443-37, 73069-443-36, 73069-443-35, 73069-443-34, 73069-443-33, 73069-443-32, 73069-443-31, 73069-443-67, 73069-443-79, 73069-443-39, 73069-443-38, 73069-443-74, 73069-443-69, 73069-443-86, 73069-443-78 20191120 Lot Numbers: 19-S00016, Exp. May: 2020 42 vials
KVK-Tech, Inc. Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16 Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection 10702-150-16 20191120 Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN 1534 bottles
8046255 Canada Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-373-35, 73069-373-34, 73069-373-37, 73069-373-36, 73069-373-31, 73069-373-56, 73069-373-19, 73069-373-18, 73069-373-17, 73069-373-16, 73069-373-15, 73069-373-14, 73069-373-13, 73069-373-12, 73069-373-11, 73069-373-29, 73069-373-55, 73069-373-57, 73069-373-51, 73069-373-88, 73069-373-38, 73069-373-33, 73069-373-39, 73069-373-85, 73069-373-32, 73069-373-58, 73069-373-84, 73069-373-48, 73069-373-86, 73069-373-87, 73069-373-54, 73069-373-81, 73069-373-68, 73069-373-49, 73069-373-66, 73069-373-53, 73069-373-64, 73069-373-65, 73069-373-62, 73069-373-59, 73069-373-61, 73069-373-41, 73069-373-42, 73069-373-43, 73069-373-44, 73069-373-45, 73069-373-46, 73069-373-47, 73069-373-22, 73069-373-23, 73069-373-21, 73069-373-26, 73069-373-27, 73069-373-24, 73069-373-25, 73069-373-89, 73069-373-67, 73069-373-52, 73069-373-28, 73069-373-69, 73069-373-82, 73069-373-63, 73069-373-79, 73069-373-78, 73069-373-83, 73069-373-71, 73069-373-73, 73069-373-72, 73069-373-75, 73069-373-74, 73069-373-77, 73069-373-76 20191120 Lot Numbers: 19-S00010, Exp. May: 2020 7 vials
8046255 Canada Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-206-54, 73069-206-55, 73069-206-56, 73069-206-57, 73069-206-76, 73069-206-51, 73069-206-52, 73069-206-53, 73069-206-73, 73069-206-78, 73069-206-79, 73069-206-58, 73069-206-59, 73069-206-71, 73069-206-87, 73069-206-72, 73069-206-77, 73069-206-36, 73069-206-74, 73069-206-37, 73069-206-38, 73069-206-75, 73069-206-21, 73069-206-23, 73069-206-22, 73069-206-25, 73069-206-24, 73069-206-27, 73069-206-26, 73069-206-29, 73069-206-28, 73069-206-67, 73069-206-66, 73069-206-61, 73069-206-63, 73069-206-62, 73069-206-47, 73069-206-46, 73069-206-45, 73069-206-44, 73069-206-43, 73069-206-42, 73069-206-41, 73069-206-39, 73069-206-49, 73069-206-48, 73069-206-83, 73069-206-65, 73069-206-81, 73069-206-84, 73069-206-86, 73069-206-85, 73069-206-64, 73069-206-89, 73069-206-88, 73069-206-69, 73069-206-68, 73069-206-82, 73069-206-18, 73069-206-19, 73069-206-34, 73069-206-35, 73069-206-32, 73069-206-33, 73069-206-31, 73069-206-11, 73069-206-12, 73069-206-13, 73069-206-14, 73069-206-15, 73069-206-16, 73069-206-17 20191120 Lot Numbers: 19-S00009, Exp. May: 2020 3 vials
8046255 Canada Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-347-69, 73069-347-68, 73069-347-85, 73069-347-84, 73069-347-83, 73069-347-45, 73069-347-59, 73069-347-86, 73069-347-61, 73069-347-63, 73069-347-44, 73069-347-65, 73069-347-64, 73069-347-67, 73069-347-66, 73069-347-25, 73069-347-24, 73069-347-27, 73069-347-26, 73069-347-47, 73069-347-46, 73069-347-23, 73069-347-22, 73069-347-49, 73069-347-48, 73069-347-29, 73069-347-28, 73069-347-82, 73069-347-31, 73069-347-81, 73069-347-89, 73069-347-37, 73069-347-88, 73069-347-52, 73069-347-34, 73069-347-35, 73069-347-62, 73069-347-32, 73069-347-78, 73069-347-79, 73069-347-76, 73069-347-77, 73069-347-74, 73069-347-75, 73069-347-72, 73069-347-73, 73069-347-71, 73069-347-51, 73069-347-38, 73069-347-39, 73069-347-18, 73069-347-19, 73069-347-56, 73069-347-57, 73069-347-14, 73069-347-15, 73069-347-16, 73069-347-17, 73069-347-36, 73069-347-11, 73069-347-12, 73069-347-13, 73069-347-43, 73069-347-33, 73069-347-42, 73069-347-58, 73069-347-41, 73069-347-54, 73069-347-87, 73069-347-53, 73069-347-21, 73069-347-55 20191120 Lot Numbers: 19-S00002, Exp. May: 2020 61 vials
Lannett Company Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80 CGMP Deviations: Presence of NDMA impurity detected in product. 54838-550-80 20191120 1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020 1646A 02/2020 1647A 02/2020 1668A 03/2020 1669A 03/2020 1670A 03/2020 1708A 03/2020 1709A 04/2020 1710A 04/2020 1729A 04/2020 1730A 04/2020 1731A 04/2020 1757A 05/2020 1758A 05/2020 1759A 05/2020 1773A 06/2020 1774A 06/2020 1989A 12/2020 1794A 06/2020 1795A 06/2020 1796A 06/2020 1817A 06/2020 1818A 07/2020 1819A 07/2020 1840A 08/2020 1840B 08/2020 1841A 08/2020 1842A 08/2020 1863A 08/2020 1864A 09/2020 1865A 09/2020 1899A 10/2020 1900A 10/2020 1901A 10/2020 1910A 10/2020 1911A 10/2020 1912A 10/2020 1918A 10/2020 1919A 10/2020 1920A 10/2020 1925A 10/2020 1926A 10/2020 1927A 10/2020 1977A 12/2020 1978A 12/2020 1979A 12/2020 1990A 12/2020 1991A 12/2020 1998A 01/2021 1999A 01/2021 2000A 01/2021 2019A 01/2021 2020A 01/2021 2065A 03/2021 2066A 03/2021 2067A 03/2021 2071A 03/2021 2072A 03/2021 2073A 03/2021 2076A 03/2021 2077A 03/2021 2078A 03/2021 2126A 05/2021 2127A 05/2021 2128A 05/2021 2164A 06/2021 2165A 06/2021 2166A 06/2021 2179A 06/2021 2180A 07/2021 2181A 07/2021 2214A 08/2021 2215A 08/2021 2216A 08/2021 683,149 bottles
Sato Pharmaceut WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, Subpotent Drug 0363-1407-01, 0363-1407-02 20191120 Lot #: a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021 a) 112,104 units b) 24,696 units
8046255 Canada Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-500-81, 73069-500-79, 73069-500-86, 73069-500-87, 73069-500-85, 73069-500-33, 73069-500-68, 73069-500-69, 73069-500-66, 73069-500-67, 73069-500-64, 73069-500-32, 73069-500-62, 73069-500-63, 73069-500-61, 73069-500-41, 73069-500-28, 73069-500-29, 73069-500-44, 73069-500-45, 73069-500-46, 73069-500-47, 73069-500-22, 73069-500-49, 73069-500-21, 73069-500-26, 73069-500-27, 73069-500-24, 73069-500-25, 73069-500-58, 73069-500-82, 73069-500-39, 73069-500-83, 73069-500-38, 73069-500-71, 73069-500-59, 73069-500-78, 73069-500-65, 73069-500-55, 73069-500-88, 73069-500-73, 73069-500-72, 73069-500-75, 73069-500-74, 73069-500-77, 73069-500-76, 73069-500-35, 73069-500-34, 73069-500-37, 73069-500-36, 73069-500-31, 73069-500-56, 73069-500-19, 73069-500-18, 73069-500-17, 73069-500-16, 73069-500-15, 73069-500-14, 73069-500-13, 73069-500-12, 73069-500-11, 73069-500-53, 73069-500-54, 73069-500-52, 73069-500-84, 73069-500-23, 73069-500-42, 73069-500-89, 73069-500-48, 73069-500-43, 73069-500-57, 73069-500-51 20191120 Lot Numbers: 19-S00007, Exp. May: 2020 5 vials
Sato Pharmaceut Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535 Subpotent Drug 59779-534-01, 0504283455 20191120 Lot #: TXWP, TXTP, Exp. date Jul 2020; AXTZ, Exp. date Mar 2021; AXNP, Exp. date Jul 2021; AXBC, Exp. date Oct 2021; ZXWW, Exp. date Dec 2021 210,744 units
8046255 Canada Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-035-78, 73069-035-39, 73069-035-66, 73069-035-61, 73069-035-43, 73069-035-49, 73069-035-48, 73069-035-29, 73069-035-28, 73069-035-67, 73069-035-42, 73069-035-25, 73069-035-24, 73069-035-27, 73069-035-26, 73069-035-21, 73069-035-41, 73069-035-23, 73069-035-22, 73069-035-34, 73069-035-47, 73069-035-63, 73069-035-46, 73069-035-79, 73069-035-45, 73069-035-75, 73069-035-88, 73069-035-87, 73069-035-86, 73069-035-85, 73069-035-44, 73069-035-83, 73069-035-82, 73069-035-81, 73069-035-32, 73069-035-69, 73069-035-89, 73069-035-33, 73069-035-58, 73069-035-59, 73069-035-74, 73069-035-31, 73069-035-72, 73069-035-73, 73069-035-71, 73069-035-51, 73069-035-52, 73069-035-53, 73069-035-54, 73069-035-55, 73069-035-56, 73069-035-37, 73069-035-14, 73069-035-15, 73069-035-16, 73069-035-17, 73069-035-36, 73069-035-11, 73069-035-12, 73069-035-13, 73069-035-76, 73069-035-38, 73069-035-35, 73069-035-18, 73069-035-19, 73069-035-62, 73069-035-65, 73069-035-57, 73069-035-68, 73069-035-84, 73069-035-77, 73069-035-64 20191120 Lot Numbers: 19-S00021, Exp. May: 2020 6 vials
8046255 Canada Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-024-89, 73069-024-72, 73069-024-82, 73069-024-87, 73069-024-85, 73069-024-84, 73069-024-16, 73069-024-45, 73069-024-14, 73069-024-15, 73069-024-12, 73069-024-13, 73069-024-11, 73069-024-39, 73069-024-31, 73069-024-32, 73069-024-33, 73069-024-34, 73069-024-21, 73069-024-18, 73069-024-19, 73069-024-52, 73069-024-53, 73069-024-76, 73069-024-51, 73069-024-56, 73069-024-57, 73069-024-54, 73069-024-55, 73069-024-41, 73069-024-58, 73069-024-59, 73069-024-78, 73069-024-79, 73069-024-35, 73069-024-75, 73069-024-43, 73069-024-42, 73069-024-37, 73069-024-74, 73069-024-86, 73069-024-66, 73069-024-29, 73069-024-28, 73069-024-49, 73069-024-48, 73069-024-23, 73069-024-22, 73069-024-47, 73069-024-46, 73069-024-27, 73069-024-26, 73069-024-25, 73069-024-24, 73069-024-67, 73069-024-38, 73069-024-65, 73069-024-64, 73069-024-63, 73069-024-62, 73069-024-61, 73069-024-17, 73069-024-81, 73069-024-88, 73069-024-83, 73069-024-73, 73069-024-71, 73069-024-77, 73069-024-69, 73069-024-68, 73069-024-44, 73069-024-36 20191120 Lot Numbers: 19-S00005, Exp. May: 2020 4 vials
Apotex Inc. Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716 GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). 49035-117-06 20191120 All lots remaining within expiry. 162,344 bottles
8046255 Canada Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-450-21, 73069-450-22, 73069-450-23, 73069-450-24, 73069-450-25, 73069-450-26, 73069-450-27, 73069-450-42, 73069-450-43, 73069-450-66, 73069-450-41, 73069-450-46, 73069-450-47, 73069-450-44, 73069-450-45, 73069-450-75, 73069-450-55, 73069-450-49, 73069-450-57, 73069-450-79, 73069-450-51, 73069-450-67, 73069-450-69, 73069-450-53, 73069-450-54, 73069-450-18, 73069-450-64, 73069-450-52, 73069-450-74, 73069-450-19, 73069-450-28, 73069-450-48, 73069-450-86, 73069-450-78, 73069-450-29, 73069-450-11, 73069-450-13, 73069-450-12, 73069-450-15, 73069-450-14, 73069-450-17, 73069-450-16, 73069-450-33, 73069-450-32, 73069-450-31, 73069-450-56, 73069-450-37, 73069-450-36, 73069-450-35, 73069-450-34, 73069-450-77, 73069-450-73, 73069-450-39, 73069-450-38, 73069-450-59, 73069-450-58, 73069-450-71, 73069-450-61, 73069-450-62, 73069-450-63, 73069-450-65, 73069-450-87, 73069-450-84, 73069-450-85, 73069-450-82, 73069-450-83, 73069-450-81, 73069-450-68, 73069-450-72, 73069-450-88, 73069-450-89, 73069-450-76 20191120 Lot Numbers: 19-S00024, Exp. May: 2020 1 vial
8046255 Canada Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-320-26, 73069-320-27, 73069-320-24, 73069-320-25, 73069-320-22, 73069-320-23, 73069-320-73, 73069-320-21, 73069-320-65, 73069-320-33, 73069-320-28, 73069-320-29, 73069-320-44, 73069-320-45, 73069-320-46, 73069-320-47, 73069-320-66, 73069-320-41, 73069-320-42, 73069-320-43, 73069-320-79, 73069-320-68, 73069-320-69, 73069-320-48, 73069-320-49, 73069-320-78, 73069-320-81, 73069-320-82, 73069-320-83, 73069-320-84, 73069-320-85, 73069-320-86, 73069-320-87, 73069-320-88, 73069-320-89, 73069-320-71, 73069-320-39, 73069-320-38, 73069-320-75, 73069-320-77, 73069-320-31, 73069-320-19, 73069-320-18, 73069-320-35, 73069-320-34, 73069-320-37, 73069-320-36, 73069-320-13, 73069-320-12, 73069-320-11, 73069-320-76, 73069-320-17, 73069-320-16, 73069-320-15, 73069-320-14, 73069-320-57, 73069-320-56, 73069-320-55, 73069-320-54, 73069-320-53, 73069-320-52, 73069-320-51, 73069-320-72, 73069-320-59, 73069-320-58, 73069-320-62, 73069-320-63, 73069-320-32, 73069-320-64, 73069-320-61, 73069-320-74, 73069-320-67 20191120 Lot Numbers: 19-S00022, Exp. May: 2020 2 vials
Novitium Pharma Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40 CGMP Deviations: Presence of NDMA impurity detected in product. 20191120 all lots within expiry. 2718 bottles
8046255 Canada Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-095-67, 73069-095-66, 73069-095-65, 73069-095-64, 73069-095-63, 73069-095-62, 73069-095-61, 73069-095-75, 73069-095-81, 73069-095-83, 73069-095-42, 73069-095-85, 73069-095-84, 73069-095-69, 73069-095-68, 73069-095-77, 73069-095-37, 73069-095-71, 73069-095-38, 73069-095-72, 73069-095-39, 73069-095-82, 73069-095-73, 73069-095-16, 73069-095-17, 73069-095-14, 73069-095-15, 73069-095-12, 73069-095-13, 73069-095-11, 73069-095-31, 73069-095-32, 73069-095-33, 73069-095-34, 73069-095-35, 73069-095-18, 73069-095-19, 73069-095-52, 73069-095-53, 73069-095-76, 73069-095-51, 73069-095-56, 73069-095-57, 73069-095-54, 73069-095-55, 73069-095-58, 73069-095-59, 73069-095-78, 73069-095-36, 73069-095-79, 73069-095-45, 73069-095-87, 73069-095-44, 73069-095-86, 73069-095-21, 73069-095-89, 73069-095-88, 73069-095-41, 73069-095-43, 73069-095-74, 73069-095-29, 73069-095-28, 73069-095-49, 73069-095-48, 73069-095-23, 73069-095-22, 73069-095-47, 73069-095-46, 73069-095-27, 73069-095-26, 73069-095-25, 73069-095-24 20191120 Lot Numbers: 19-S00014, Exp. May: 2020 22 vials
Amneal Pharmace Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. 69238-1176-1, 69238-1175-3, 69238-1175-1, 69238-1174-3, 69238-1174-1, 69238-1017-3, 69238-1017-1, 69238-1176-3 20191120 Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019 2460 cartons/3 blister cards/10 capsules each
Golden State Me GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. CGMP Deviations: Presence of NDMA impurity detected in product. 51407-097-05, 51407-098-01 20191120 Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.
8046255 Canada Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41. Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 73069-244-82, 73069-244-89, 73069-244-77, 73069-244-44, 73069-244-16, 73069-244-45, 73069-244-14, 73069-244-15, 73069-244-12, 73069-244-13, 73069-244-11, 73069-244-31, 73069-244-32, 73069-244-33, 73069-244-34, 73069-244-21, 73069-244-18, 73069-244-19, 73069-244-52, 73069-244-53, 73069-244-76, 73069-244-51, 73069-244-56, 73069-244-57, 73069-244-54, 73069-244-55, 73069-244-41, 73069-244-58, 73069-244-59, 73069-244-78, 73069-244-79, 73069-244-35, 73069-244-72, 73069-244-39, 73069-244-43, 73069-244-87, 73069-244-36, 73069-244-42, 73069-244-37, 73069-244-74, 73069-244-71, 73069-244-66, 73069-244-75, 73069-244-86, 73069-244-29, 73069-244-28, 73069-244-49, 73069-244-48, 73069-244-23, 73069-244-22, 73069-244-47, 73069-244-46, 73069-244-27, 73069-244-26, 73069-244-25, 73069-244-24, 73069-244-67, 73069-244-38, 73069-244-65, 73069-244-64, 73069-244-63, 73069-244-62, 73069-244-61, 73069-244-17, 73069-244-81, 73069-244-83, 73069-244-73, 73069-244-85, 73069-244-84, 73069-244-69, 73069-244-68, 73069-244-88 20191120 Lot Numbers: 19-S00023, Exp. May: 2020 18 vials

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