Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class III · Low risk
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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 III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: