Key Takeaway
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 Correctiv by Valeant Pharmaceuticals was recalled on October 15, 2012. The hazard: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is...
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 Correctiv
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.
Hazard / Reason
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.
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
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 Correctiv
DrugsCompany Information
Valeant Pharmaceuticals
Bridgewater, NJ, United States
View all 8 recalls by Valeant Pharmaceuticals →Distribution
Nationwide
Related Recalls
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
October 15, 2012
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
October 15, 2012
AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
October 15, 2012
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-c
October 15, 2012
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
October 15, 2012
AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
October 15, 2012
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.