November 11, 2020DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
November 11, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubila
Hazard: Subpotent
November 11, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 m
Hazard: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
November 11, 2020DrugsFDA
Teligent Pharma, Inc. recalls Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60
Hazard: Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
November 11, 2020DrugsFDA
Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
November 11, 2020DrugsFDA
Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
November 11, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
Direct Rx recalls Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
Denton Pharma, Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
November 11, 2020DrugsFDA
Medichem S.A. recalls Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
Hazard: Discoloration.
November 4, 2020DrugsFDA
Jarrow Formulas Inc recalls N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC:
Hazard: Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
November 4, 2020DrugsFDA
Bausch Health Companies, Inc. recalls Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Va
Hazard: SUBPOTENT DRUG
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
November 4, 2020DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharm
Hazard: An extraneous peak was observed for dissolution testing.
November 4, 2020DrugsFDA
RemedyRepack Inc. recalls Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indi
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
October 28, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002
Hazard: Out-of-specification organic impurity results obtained during routine stability testing.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
ANI Pharmaceuticals, Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixe
Hazard: Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
October 28, 2020DrugsFDA
eVenus Pharmaceutical Laboratories recalls Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Sha
Hazard: DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
October 28, 2020DrugsFDA
Genesis Partnership Company SA recalls Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A.
Hazard: Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
October 28, 2020DrugsFDA
Genesis Partnership Company SA recalls Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Gu
Hazard: Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
October 28, 2020DrugsFDA
Genesis Partnership Company SA recalls Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis P
Hazard: CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
October 28, 2020DrugsFDA
Genesis Partnership Company SA recalls Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Pa
Hazard: CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.