Class II · Moderate risk Ongoing
Chlorpromazine Hydrochloride Tablets
Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Drug Recalls
2,661 recalls, newest first
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
Class I · High risk Ongoing
Cyclobenzaprine Hydrochloride Tablets
Reason Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.