TRIPENICOL S Antifungal Solution Recalled for CGMP Deviations
Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) because the firm discontinued required stability testing for products still on the market within their expiration date.
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 recall involving CGMP deviations (discontinuation of stability testing). No illnesses or injuries are reported in the source text, and the hazard is a manufacturing process deviation rather than confirmed product contamination or defect. FDA Class II recalls without reported illness or injury typically fall in the Moderate range.
Plain-English summary
Blaine Labs Inc is recalling TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottles, NDC 73352-550-01, Lot #BL3411R with expiration date 6/8/2027. The recall is due to Current Good Manufacturing Practice (CGMP) deviations: the firm discontinued required stability testing for products that remain on the market and are still within their expiration date.
A total of 144 bottles were distributed nationwide in the USA. Consumers who have purchased this product should stop using it and consult their healthcare provider with any questions or concerns.
The recalled product
- Product
- TRIPENICOL S (UNDECYLENIC ACID)
- Brand
- TRIPENICOL S
- Manufacturer
- Blaine Labs Inc
- Category
- Drug — OTC Antifungal Topical
- Hazard
- cgmp-deviation
- stability-testing-failure
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 #BL3411R
- Exp 6/8/2027
Distribution
Distributed nationwide across the United States.
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