July 1, 2020DrugsFDA
Rising Pharmaceuticals, Inc. recalls Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed
Hazard: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
July 1, 2020DrugsFDA
Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactur
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Phar
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharm
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amnea
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewat
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amn
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amne
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amne
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Pfizer Inc. recalls Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (3
Hazard: Failed Dissolution Specifications
July 1, 2020DrugsFDA
Alembic Pharmaceuticals Limited recalls Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formu
Hazard: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
July 1, 2020DrugsFDA
Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc.
Hazard: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
July 1, 2020DrugsFDA
Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc
Hazard: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
July 1, 2020DrugsFDA
A.P. Deauville, LLC recalls Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, N
Hazard: cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
July 1, 2020DrugsFDA
QuVa Pharma, Inc. recalls R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded
Hazard: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
July 1, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceu
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 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 72789-00
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10),
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-1
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 1, 2020DrugsFDA
BIOTA Biosciences LLC recalls Sterile Curcumin 50mg/mL, 10 mL vial
Hazard: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
July 1, 2020DrugsFDA
BIOTA Biosciences LLC recalls Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Hazard: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
July 1, 2020DrugsFDA
BIOTA Biosciences LLC recalls Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Hazard: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
July 1, 2020DrugsFDA
BIOTA Biosciences LLC recalls Sterile Curcumin, 4mg/mL, 10mL vial
Hazard: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
July 1, 2020DrugsFDA
BIOTA Biosciences LLC recalls Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Hazard: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
June 24, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Cons
Hazard: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
June 24, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcar
Hazard: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.