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
316 recalls, 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 I · High risk
DYNAMITE SUPER capsule
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
NUX Male Enhancement capsule
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
Pro Power Knight Plus capsule
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
Lidocaine Patch 5%
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.