Drug product
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
D-048-2013
Product summary
- Event
- Event 63488
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,434 canisters
- Official record key
drug-enforcement:D-048-2013
Official wording
Reason: 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.
Code information: All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled
-
Potency or specification failure
Subpotent