DermaSarra Camphor External Analgesic Recalled Due to Manufacturing Defect
DermaSarra Camphor 0.5% external analgesic is being recalled due to a manufacturing practice deviation at the production facility. The recall affects 2,389 bottles distributed nationwide.
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: This is an FDA Class II precautionary recall based on a CGMP deviation with no reported illnesses or injuries. The source indicates contamination was found in other products at the facility, but does not specify contamination of this product or any patient harm, consistent with voluntary precautionary recall criteria.
Plain-English summary
DermaSarra Camphor 0.5% external analgesic (222 mL bottles) is being recalled by DermaRite Industries, LLC. The recall is due to a Current Good Manufacturing Practice (CGMP) deviation discovered at the manufacturing facility. During investigation, other products and lots manufactured at the same facility were found to be contaminated.
This recall affects all DermaSarra Camphor 0.5% lots with expiration dates on or before August 2027. A total of 2,389 bottles were distributed nationwide.
Consumers should stop using this product and contact DermaRite Industries for return instructions. For more information, visit the FDA's Drug Recalls page at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical Analgesic
- Hazard
- cgmp-deviation
- contamination-risk
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)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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