Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Mertiatide
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk
Viorele
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
bevacizumab
Lack of Assurance of Sterility
Class II · Moderate risk
Aripiprazole Tablets
Superpotent drug
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.