Home / Recalls / Valeant Pharmaceuticals / D-043-2013

D-043-2013 Class III Terminated

Recalled by Valeant Pharmaceuticals — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
November 14, 2012
Initiation Date
October 15, 2012
Termination Date
March 25, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
477,107 cartons

Product Description

AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.

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.

Distribution Pattern

Nationwide

Code Information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3

Other recalls by Valeant Pharmaceuticals

  • D-047-2013 Class III — AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (October 15, 2012)
  • D-045-2013 Class III — AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tu (October 15, 2012)
  • D-044-2013 Class III — AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) (October 15, 2012)
  • D-046-2013 Class III — AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per j (October 15, 2012)
  • D-048-2013 Class III — AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 (October 15, 2012)
  • D-042-2013 Class III — AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Pu (October 15, 2012)
  • D-049-2013 Class III — AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, D (October 15, 2012)