Class II · Moderate risk Ongoing
Rocuronium Bromide 50 mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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
Class II · Moderate risk Ongoing
Methocarbamol Injection USP 1
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk Completed
Venlafaxine Tablets
Reason Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP 40 mg
Reason Failed dissolution specifications: lower than specifications
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules USP
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Cetirizine Hydrochloride Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Acetaminophen and Ibuprofen
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Saxagliptin Tablets
Reason CGMP Deviations