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.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 Completed
Calcitonin Salmon
Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class II · Moderate risk Terminated
Fyremadel
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
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 Completed
Pantoprazole sodium for Injection 40 mg*/vial
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk Terminated
Simvastatin USP 40 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP 20 mg
Reason CGMP deviations.
Class II · Moderate risk Terminated
Glimepiride USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Simvastatin USP
Reason CGMP deviations.
Class II · Moderate risk Terminated
Montelukast Sodium USP
Reason CGMP deviations.
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.