Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-043-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 15, 2012
- FDA report date
- Nov 14, 2012
- Quantity
- 477,107 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-043-2013, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63488
- Address
- 700 Rte 206 North
- Code information
- All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
- Postal code
- 08807
- Report date
- Nov 14, 2012
- Product type
- Drugs
- Recall number
- D-043-2013
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals
- Product quantity
- 477,107 cartons
- Termination date
- Mar 25, 2013
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 15, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2012