Status
Terminated
Drug Enforcement D-042-2013
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.
Classification
Class III
Report Date
November 14, 2012
Termination Date
March 25, 2013
Product Information
- Product description
- 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-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
- Product quantity
- 1,097,846 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Valeant Pharmaceuticals
- Address
-
700 Rte 206 North, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-042-2013
- Event ID
- 63488
- Recall initiation date
- October 15, 2012
- Center classification date
- November 6, 2012
- Code info
- All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
- More code info
- —