Drug product
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
D-042-2013
Product summary
- Event
- Event 63488
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,097,846 cartons
- Official record key
drug-enforcement:D-042-2013
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 12008 6
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled
-
Potency or specification failure
Subpotent