Valeant Recalls Cortaid 12-Hour Anti-itch Cream Due to cGMP Deviations
Valeant Pharmaceuticals is recalling 5,016 tubes of Cortaid 12-Hour Advanced Anti-itch Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.
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 II. The source text explicitly states that no positive results for microbial contamination were obtained for the firm's products, and the recall is driven by identified cGMP deviations rather than confirmed illness or injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valeant Pharmaceuticals North America LLC is voluntarily recalling 5,016 tubes of Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), 1.5 oz. The affected product is identified by Lot # 172185F and an expiration date of 6/19. The product was distributed throughout the United States.
The recall was initiated after the firm received notice from a supplier regarding a voluntary recall of the supplier's nasal products and baby oral gels due to the possibility of microbial contamination. Although no positive results for microbial contamination were obtained for the firm's products, a subsequent review by Valeant revealed current Good Manufacturing Practice (cGMP) deviations.
Consumers who have purchased this specific lot of Cortaid 12-Hour Advanced Anti-itch Cream should stop using the product and contact Valeant Pharmaceuticals North America LLC for further instructions or a refund.
The recalled product
- Product
- Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Topical Steroid
- Affected units
- 5,016
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 (2)
- Lot #: 172185F
- Exp 6/19
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Valeant Pharmaceuticals North America LLC 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.
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