Class II · Moderate risk
Methylcobalamin 12mg/ml injection
Lack of Processing Controls
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
Class II · Moderate risk
5% Dextrose Injection
Lack of sterility assurance: bag has the potential to leak.
Class II · Moderate risk
Pain Aid Esf-
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class II · Moderate risk
Moxifloxacin
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk
Diclofenac Sodium Topical Solution
Defective container: Out of specification for container integrity leading to bottles leaking.
Class II · Moderate risk
Secret Dry Spray
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Old Spice
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Old Spice
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Old Spice
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Old Spice Pure Sport 2021 Gift Set
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret OUTLAST Dry Spray
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Secret
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Old Spice
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Product Mix-up
Class II · Moderate risk
Ascorbic Acid Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Biotin Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl
Lack of Assurance of Sterility