Drug 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.
D-046-2013
Product summary
- Event
- Event 63488
- Status
- Terminated
- Classification
- Class III
- Quantity
- 71,369 jars
- Official record key
drug-enforcement:D-046-2013
Official wording
Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Code information: All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent