Enforcement Report - Week of November 14, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | D-048-2013 |
| Classification | Class III |
| Code Info | All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9 |
| Product Distributed Qty | 10,434 canisters |
| 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. |
Event Detail
| Event Id | 63488 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Valeant Pharmaceuticals |
| City | Bridgewater |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
-
