Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser
Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issues involve subpotency and labeling errors, fitting the criteria for moderate severity.
Plain-English summary
Valeant Pharmaceuticals is recalling 145,650 bottles of AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottles. The product is distributed by University Medical Pharmaceuticals Corp. in Irvine, CA, and was sold nationwide. The recall covers all lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8.
The recall was initiated because the product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, the product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Consumers should check their products for the specific UPC and expiration date range listed above. If the product matches the description, consumers should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
- Manufacturer
- Valeant Pharmaceuticals
- Category
- Drug — Topical OTC
- Affected units
- 145,650
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 →Related recalls
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