Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL
Reason cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
Kit for the Preparation of Technetium Tc 99m Mertiatide
Reason Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class II · Moderate risk Ongoing
Viorele
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Sulfamethoxazole and Trimethoprim
Reason 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 Ongoing
Sulfamethoxazole and Trimethoprim
Reason 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 Ongoing
Norgestimate and Ethinyl Estradiol Tablets
Reason Failed Content Uniformity Specifications