Prescription & OTC drugs recalls
Every prescription & otc drugs recall on file, newest first, each one linked back to the federal notice it came from.
-
Class II · 1+ years ago
Glenmark Pharmaceuticals Inc., USA Azelaic Acid Gel, 15%, 50 grams recall: CGMP Deviations: Market complaints received for gritty texture (grainy)
CGMP Deviations: Market complaints received for gritty texture (grainy)
-
Class II · 1+ years ago
Northwind Pharmaceuticals LLC Sulfamethoxazole and Trimethoprim Tablets recall: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
-
Class II · 1+ years ago
Sandoz Inc Cyclophosphamide Injection 500 mg/5 mL , Hazardous Drug recall: cGMP deviations: Temperature excursion during transportation
cGMP deviations: Temperature excursion during transportation.
-
Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 0.5 mg, 30 Tablets recall: Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
-
Class I · 1+ years ago
Unichem Pharmaceuticals USA Inc. Cyclobenzaprine Hydrochloride Tablets, USP recall: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets…
-
Class II · 1+ years ago
Amerisource Health Services LLC chlorproMazine Hydrochloride Tablets, USP, 25 mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…
-
Class II · 1+ years ago
Sun Pharmaceutical Industries Inc Kit for the Preparation of Technetium Tc 99m recall: Failed Dissolution Specifications-Out of Specification (OOS) observation
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…
-
Class II · 1+ years ago
Ascend Laboratories, LLC Aripiprazole Tablets, USP, 10 mg, 30-count bottles recall: Superpotent drug
Superpotent drug
-
Class II · 1+ years ago
Amerisource Health Services LLC chlorproMazine Hydrochloride Tablets, USP, 100 mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…
-
Class II · 1+ years ago
B Braun Medical Inc Sterile Water FOR Injection USP, 3000mL recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
-
Class II · 1+ years ago
B Braun Medical Inc 0.9% Sodium Chloride Irrigation USP. Isotonic Solution recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
-
Class II · 1+ years ago
Amerisource Health Services LLC chlorproMazine Hydrochloride Tablets, USP, 50 mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…
-
Class II · 1+ years ago
Amerisource Health Services LLC chlorproMazine Hydrochloride Tablets, USP, 200 mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…
-
Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 1 mg, 30 Tablets recall: Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
-
Class II · 1+ years ago
Fagron Compounding Services bevacizumab Injection, 1.25mg/0.05mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class II · 1+ years ago
Major Pharmaceuticals and Rugby Laboratories Sulfamethoxazole and Trimethoprim recall: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
-
Class II · 1+ years ago
Lannett Company Inc. Dextroamphetamine Saccharate, Amphetamine Aspartate recall: Presence of Foreign Tablet/Capsule: Two (2) bottles labeled
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and…
-
Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 10 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
-
Class II · 1+ years ago
Major Pharmaceuticals and Rugby Laboratories Sulfamethoxazole and Trimethoprim recall: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
-
Class II · 1+ years ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP, 30 mg, 1 recall: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
-
Class II · 1+ years ago
Exela Pharma Sciences LLC 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL recall: Failed Impurities/Degradation Specifications: out of specification results
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
-
Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
-
Class II · 1+ years ago
Grace & Fire Pty Ltd Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen recall: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
-
Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit