Agency classClass IIIOur severity:Low FDA (Drugs)·D-046-2013·Announced 2012-11-14

Valeant Recalls AcneFree Toner Pads Due to Low Salicylic Acid Content

Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads because the salicylic acid ingredient was found to be subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v) because the product was found to be subpotent for the salicylic acid active ingredient. The recall involves 71,369 jars of the 60-count pads, distributed nationwide by University Medical Pharmaceuticals Corp. in Irvine, CA.

The affected products are identified by UPC 7 88521 13551 6 and include all lots with expiration dates between 10/10/12 and 10/10/14. The FDA has classified this as a Class III recall, indicating that use of the product is not likely to cause adverse health consequences.

Consumers should check their products for the specific UPC and expiration date range listed above. If the product matches the recall description, consumers should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.

The recalled product

Product: 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.
Manufacturer: Valeant Pharmaceuticals
Category: Drug — Topical OTC
Hazard: subpotent-drug
Affected units: 71,369

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Valeant Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Valeant Pharmaceuticals

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Same hazard · subpotent drug