Enforcement Report - Week of November 14, 2012
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | D-043-2013 |
| Classification | Class III |
| Code Info | All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3 |
| Product Distributed Qty | 477,107 cartons |
| 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 |
-
