Class II · Moderate risk Ongoing
FentaNYL 500mcg
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Dexonto 0.4%
Reason Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class II · Moderate risk Terminated
Urodel
Reason cGMP deviations
Class II · Moderate risk Terminated
Rapidol Arnica Tablets
Reason cGMP deviations
Class II · Moderate risk Terminated
Rapidol Arnica Gel
Reason cGMP deviations
Class II · Moderate risk Terminated
Kingskin
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloEar Earache Drops
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloDent Maximum Strength Toothache Drops
Reason cGMP deviations
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
ChlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Terminated
clomiPRAMINE hydrochloride Capsules USP
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Class II · Moderate risk Ongoing
Testosterone Cypionate Injection
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk Ongoing
Wegovy
Reason Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Class II · Moderate risk Ongoing
Kapsin Ointment
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Hemopropin Ointment
Reason CGMP Deviations
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Terminated
Bimatoprost powder
Reason CGMP Deviations