Class III · Low risk Terminated
CariFree sample boxes
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
CTx36 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx26 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx21 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx7 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Labeling: Missing Label
Class III · Low risk Terminated
Morphine Sulfate Oral Solution 100 mg per 5 mL
Reason Labeling: Missing Label
Class I · High risk Terminated
Veklury
Reason Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
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 III · Low risk Terminated
Telmisartan and Hydrochlorothiazide Tablets
Reason Superpotent; Hydrochlorothiazide
Class I · High risk Terminated
Klean Touch Hand Sanitizer
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
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