Recalls / Class III
Class IIID-046-2013
Product
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.
- Affected lot / code info
- All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
Why it was recalled
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Recalling firm
- Firm
- Valeant Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 700 Rte 206 North, N/A, Bridgewater, New Jersey 08807
Distribution
- Quantity
- 71,369 jars
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-15
- FDA classified
- 2012-11-06
- Posted by FDA
- 2012-11-14
- Terminated
- 2013-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-046-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.