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AcneFree 3-in-1 Acne Night Repair Foam (Valeant) – Subpotent Ingredients (2012)

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Class IIILow

FDAOct 15, 2012Nationwide• Valeant Pharmaceuticals

AcneFree 24 Hour Clearing System (Valeant) – Subpotent Active Ingredient (2012)

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Class IIILow

FDA

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AcneFree 3-in-1 Acne Night Repair Foam (Valeant) – Subpotent Ingredients (2012)

AcneFree 24 Hour Clearing System (Valeant) – Subpotent Active Ingredient (2012)

AcneFree Oil-Free Acne Cleanser (Valeant) – Subpotent Benzoyl Peroxide (2012)

Perphenazine Tablets (Qualitest) – Tablet Coating Defect (2012)

Arranon Injection (GlaxoSmithKline) – Impurity Concerns (2012)

Lactated Ringer's Dextrose Injection (Hospira) – Potential Contamination (2012)

Lidocaine HCl Injection (Hospira) – Particulate Matter (2012)

Moexipril HCl Tablets (Paddock) – Dissolution Non-Conformity (2012)

Midazolam Hydrochloride Injection (Fresenius Kabi) – Sterility Risk (2012)

Quetiapine Fumarate Tablets (Dr. Reddy's) – Dissolution Failure (2012)

Ondansetron Injection (Fresenius Kabi) – Sterility Risk (2012)

Cyanocobalamin Injection (Fresenius Kabi) – Sterility Risk (2012)

CellCept Capsules (Genentech) – Short Fill Packaging (2012)

Lidocaine PF Injection (New England Compounding) – Sterility Risk (2012)

Lidocaine/Dextrose PF (New England Compounding) – Sterility Risk (2012)

Sodium Chloride Injection (Baxter) – Chemical Contamination (2012)

Endurance Pre Race Lime Supplement (Maine Natural Health) – Undeclared Allergens (2012)

10% Dextrose Injection USP (Baxter) – Chemical Contamination (2012)

Endurance Daily Chocolate Supplement (Maine Natural Health) – Undeclared Milk (2012)

Recovery Supplement (Maine Natural) – undeclared allergens (2012)