AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canist...
FDA Recall #D-048-2013 — Class III — October 15, 2012
Product Description
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
Reason for Recall
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.
Recalling Firm
Valeant Pharmaceuticals — Bridgewater, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
10,434 canisters
Distribution
Nationwide
Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated