Why it was recalled
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Product description
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.
Lot numbers, UPCs & expiration codes
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
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-046-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 15, 2012
- FDA report date
- Nov 14, 2012
- Quantity
- 71,369 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-046-2013, 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 13551 6
- Postal code
- 08807
- Report date
- Nov 14, 2012
- Product type
- Drugs
- Recall number
- D-046-2013
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals
- Product quantity
- 71,369 jars
- Termination date
- Mar 25, 2013
- Reason for recall
- Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 15, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2012