Class II · Moderate risk Ongoing
Artificial Tears Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
FDA Drug Recalls
2,661 recalls, newest first
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 I · High risk Ongoing
DYNAMITE SUPER capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Ongoing
NUX Male Enhancement capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Ongoing
Pro Power Knight Plus capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class III · Low risk Ongoing
Lidocaine Patch 5%
Reason Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
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.
Class II · Moderate risk Ongoing
Glimepiride Tablets USP
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Tadalafil Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Simvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Simvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Simvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Simvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.