D-046-2013 Class III Terminated
FDA drug recall D-046-2013 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 salicyclic acid active ingredient. The recall status is terminated (terminated March 25, 2013). Affected quantity: 71,369 jars.
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
- 71,369 jars
Product Description
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
Reason for Recall
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Distribution Pattern
Nationwide
Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6