Drug product
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.
D-043-2013
Product summary
- Event
- Event 63488
- Status
- Terminated
- Classification
- Class III
- Quantity
- 477,107 cartons
- Official record key
drug-enforcement:D-043-2013
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 12900 3
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled
-
Potency or specification failure
Subpotent