AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by:...
FDA Recall #D-044-2013 — Class III — October 15, 2012
Product Description
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
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
145,650 bottles
Distribution
Nationwide
Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated