AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: Uni...
FDA Drug Recall #D-046-2013 — Class III — October 15, 2012
Recall Summary
| Recall Number | D-046-2013 |
| Classification | Class III — Low risk |
| Date Initiated | October 15, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Valeant Pharmaceuticals |
| Location | Bridgewater, NJ |
| Product Type | Drugs |
| Quantity | 71,369 jars |
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.
Reason for Recall
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Distribution Pattern
Nationwide
Lot / Code Information
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
Other Recalls from Valeant Pharmaceuticals
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-048-2013 | Class III | AcneFree Severe Maximum Strength Acne Pore Clea... | Oct 15, 2012 |
| D-045-2013 | Class III | AcneFree Original Strength Terminator (benzoyl ... | Oct 15, 2012 |
| D-042-2013 | Class III | AcneFree 24 Hour Clearing System containing 1-c... | Oct 15, 2012 |
| D-044-2013 | Class III | AcneFree Oil-Free Acne Cleanser (benzoyl peroxi... | Oct 15, 2012 |
| D-043-2013 | Class III | AcneFree 24 Hour Severe Acne Clearing System co... | Oct 15, 2012 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.