AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser ...
FDA Recall #D-042-2013 — Class III — October 15, 2012
Product Description
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
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
1,097,846 cartons
Distribution
Nationwide
Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated