Valeant Recalls Cortaid Intensive Therapy Cooling Spray Due to cGMP Deviations
Valeant Pharmaceuticals is recalling specific lots of Cortaid Intensive Therapy Cooling Spray due to cGMP deviations identified after a supplier recall for microbial contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 and a theoretical risk of microbial contamination from a supplier, with no positive test results or reported illnesses for this specific product, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Valeant Pharmaceuticals North America LLC is voluntarily recalling 18,408 bottles of Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottles. The affected product is distributed throughout the United States. The recall involves specific lots: 171205E and 171951E (Expiration 5/19) and 173365K (Expiration 10/19).
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 should check their bottles for the affected lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Topical Steroid
- Affected units
- 18,408
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 (5)
- Lot #: 171205E
- 171951E
- Exp 5/19
- 173365K
- Exp 10/19
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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