Recalls / Class III
Class IIID-048-2013
Product
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.
- Affected lot / code info
- All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
Why it was recalled
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.
Recalling firm
- Firm
- Valeant Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 700 Rte 206 North, N/A, Bridgewater, New Jersey 08807
Distribution
- Quantity
- 10,434 canisters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-15
- FDA classified
- 2012-11-06
- Posted by FDA
- 2012-11-14
- Terminated
- 2013-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-048-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.