December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles
Hazard: Superpotent Drug and Subpotent Drug: potency failures obtained
December 18, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories I
Hazard: Failed Impurities/Degradation Specifications
December 18, 2024DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and
Hazard: cGMP Deviations: Temperature excursion
December 18, 2024DrugsFDA
LNK International, Inc. recalls Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorpha
Hazard: CGMP Deviations: Released product should have been rejected.
December 18, 2024DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aur
Hazard: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
December 18, 2024DrugsFDA
Biocompatibles UK, Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 V
Hazard: Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
December 11, 2024DrugsFDA
Lannett Company Inc. recalls Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelp
Hazard: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
December 11, 2024DrugsFDA
Generitech Corporation recalls 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottl
Hazard: CGMP Deviations: Inconsistency in the water systems.
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
December 11, 2024DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 10
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
December 11, 2024DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc.,
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
December 11, 2024DrugsFDA
AvKARE recalls Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902
Hazard: Labeling: Label Mix-Up
December 11, 2024DrugsFDA
AvKARE recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-90
Hazard: Labeling: Label Mix-Up
December 11, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydu
Hazard: Labeling: Not Elsewhere Classified - Wrong NDC number
December 11, 2024DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited,
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
December 11, 2024DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-4
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
December 11, 2024DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, H
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd f
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmac
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.