Valeant Recalls Cortaid Maximum Strength Cream Due to cGMP Deviations
Valeant Pharmaceuticals is recalling specific lots of Cortaid Maximum Strength 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 hazard is based on cGMP deviations identified during a review, with no positive microbial test results or reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Valeant Pharmaceuticals North America LLC is voluntarily recalling specific lots of Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tubes. The recall affects 119,594 tubes distributed throughout the United States. The affected lot numbers are 170843B, 171484D, 171791E, 171848E, 172359J, 172360J, 173184J, 173512P, 180180B, and 181098C, with expiration dates ranging from February 2019 to March 2020.
The recall was initiated after the firm received notice from a supplier regarding a voluntary recall of 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 with these specific lots of Cortaid Maximum Strength Cream should stop using the product and contact Valeant Pharmaceuticals North America LLC for further instructions or a refund.
The recalled product
- Product
- Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Topical Steroid
- Affected units
- 119,594
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 (17)
- Lot #: 170843B
- Exp 2/19
- 171484D
- Exp 4/19
- 171791E
- 171848E
- Exp 5/19
- 172359J
- 172360J
- 173184J
- Exp 9/19
- 173512P
- Exp 12/19
- 180180B
- Exp 2/20
- 181098C
- Exp 3/20
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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