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.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Clindamycin HCl
Reason CGMP Deviations
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 Ongoing
Atorvastatin Calcium Tablets USP 40 mg
Reason Failed dissolution specifications: lower than specifications
Class I · High risk Ongoing
Levetiracetam 0.75% in Sodium Chloride Injection 1
Reason LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets 150mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Colesvelam Hydrocholoride Tablets 625mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Rosuvastatin Tablets 40mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Prochlorperazine Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets
Reason CGMP Deviations