Class II · Moderate risk Ongoing
Clobetasol Propionate Ointment
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Clobetasol Propionate Cream
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Cimetidine HCl Oral Solution 300mg/5mL
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Ciclopirox Topical Solution 8%
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Cetrorelix Acetate for Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Calcitriol Injection 1 mcg/mL
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Calcipotriene Topical Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Ak-Poly-Bac
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Azelastine Hydrochloride Nasal Spray
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Artificial Tears Ointment
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Artificial Tears Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Apraclonidine Ophthalmic Solution 0.5%
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Albuterol Sulfate Syrup
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Acyclovir Oral Suspension
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Acetic Acid Otic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Reason Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Class II · Moderate risk Ongoing
C-Semaglutide 5mg/mL injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing
Admelog
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class II · Moderate risk Ongoing
Fast Acting Earwax Removal System
Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class II · Moderate risk Ongoing
Advil Liqui-Gels Solubilized Ibuprofen Capsules
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Ibuprofen Tablets
Reason CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk Ongoing
Advil Ibuprofen Tablets
Reason CGMP deviation: product outside labeled storage temperature requirements.