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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

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.
Recall Number D-042-2013
Classification Class III
Code Info All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
Product Distributed Qty 1,097,846 cartons
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.

Event Detail

Event Id 63488
Product Type Drugs
Status Ongoing
Recalling Firm Valeant Pharmaceuticals
City Bridgewater
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide