FDAFDA · Food and drugs·Recall number D-043-2013
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.
Published November 14, 2012 · Recall initiated: October 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valeant Pharmaceuticals
- Distributor
- Nationwide
- Lot
- All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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