Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed Impurity/Degradation Specifications
FDA Drug Recalls
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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
Class II · Moderate risk Ongoing
bevacizumab
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class III · Low risk Ongoing
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications:
Class II · Moderate risk Ongoing
Aripiprazole Tablets
Reason Superpotent drug
Class I · High risk Ongoing
Green Lumber Natural Fuel For Men capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil