Class II · Moderate risk
Chlorpromazine Hydrochloride Tablets
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Drug Recalls
2,357 recalls · Class II, newest first
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.
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.
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.
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.
Class II · Moderate risk
Neuroquell & Neuroquell Plus
cGMP violations
Class II · Moderate risk
Succinylcholine Chloride Injection
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II · Moderate risk
UltraSure Anti-Perspirant & Deodorant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
San-E-Foam
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew Skin Repair Cream
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew PeriProtect
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
PeriGuard Ointment
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
PeriGiene
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.