D-044-2013 Class III Terminated
FDA drug recall D-044-2013 was initiated by Valeant Pharmaceuticals on October 15, 2012 and is designated Class III. 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 erron… The recall status is terminated (terminated March 25, 2013). Affected quantity: 145,650 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2012
- Initiation Date
- October 15, 2012
- Termination Date
- March 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,650 bottles
Product Description
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.
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.
Distribution Pattern
Nationwide
Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8