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

Firm: Valeant Pharmaceuticals

Classification: Class III

Status: Terminated

Report Date: 20121114

Initiation Date: 20121015

Termination Date: 20130325

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.

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.