Valeant Recalls Acanya Gel Samples Due to Incorrect Expiration Date
Valeant Pharmaceuticals is recalling 45,000 tubes of Acanya gel physician samples because they were assigned an incorrect expiration date.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation/labeling error (incorrect expiration date) rather than a direct safety hazard like contamination or misbranding of active ingredients.
Plain-English summary
Valeant Pharmaceuticals North Am is recalling 45,000 tubes of Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g. The product is a prescription-only sample intended for physicians and is not for sale. The specific lot affected is AC27198F6, with NDC 13548-132-03.
The recall is being conducted because an incorrect expiration date was assigned to this lot of physician samples. This is a labeling issue regarding the product's date information rather than a contamination or manufacturing defect in the gel itself.
The affected samples were distributed in the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations, as the expiration date is inaccurate.
The recalled product
- Product
- Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03
- Manufacturer
- Valeant Pharmaceuticals North Am
- Hazard
- Affected units
- 45,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot AC27198F6
Distribution
Distribution scope not specified by the agency.
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