Class II · Moderate risk Ongoing
Clobetasol Propionate Shampoo
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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Class II · Moderate risk Ongoing
Clobetasol Propionate Ointment
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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 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 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 III · Low risk Terminated
Gabapentin Tablets
Reason Product mixup: one foreign tablet found in product.
Class I · High risk Terminated
G-Supress DX
Reason Product mix-up: incorrect product was found inside the G-Supress DX product carton.
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.