Class II · Moderate risk
Dicyclomine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
FDA Drug Recalls
948 recalls · Class II, newest first
Class II · Moderate risk
DetomiSed (detomidine hydrochloride)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Shampoo
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Ointment
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Clobetasol Propionate Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Cimetidine HCl Oral Solution 300mg/5mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ciclopirox Topical Solution 8%
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Cetrorelix Acetate for Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Calcitriol Injection 1 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Calcipotriene Topical Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ak-Poly-Bac
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Azelastine Hydrochloride Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Artificial Tears Ointment
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Artificial Tears Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Apraclonidine Ophthalmic Solution 0.5%
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Albuterol Sulfate Syrup
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acetic Acid Otic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Calcitonin Salmon
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class II · Moderate risk
Fyremadel (ganirelix acetate)
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class II · Moderate risk
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Class II · Moderate risk
C-Semaglutide 5mg/mL injection
Lack of assurance of sterility.