Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
FDA Drug Recalls
17,898 recalls, newest first
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
Class II · Moderate risk Ongoing
Rocuronium Bromide 50 mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Ketamine HCl 50mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
dexmedeTOMIDine HCl PF
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Glycopyrrolate
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
0.9% Sodium chloride Irrigation USP
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Unisom
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · Moderate risk Ongoing
Clindamycin HCl
Reason CGMP Deviations
Class II · Moderate risk Terminated
Voriconazole Tablets
Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 100mg/mL
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 50mg/mL
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection 50mg/mL
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination