Class II · Moderate risk Terminated
Medique Pain-Off
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Physicians CARE Extra Strength PAIN RELIEVER
Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk Terminated
B-Complex
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Methylcobalamin 12mg/ml injection
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Carbamazepine Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of sterility assurance: bag has the potential to leak.
Class II · Moderate risk Terminated
Pain Aid Esf-
Reason CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class II · Moderate risk Terminated
Moxifloxacin
Reason Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk Terminated
Secret Dry Spray
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Old Spice
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Old Spice
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Old Spice
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Old Spice Pure Sport 2021 Gift Set
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret OUTLAST Dry Spray
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Secret
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Old Spice
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets
Reason Product Mix-up
Class II · Moderate risk Terminated
Ascorbic Acid Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility