Recalls / Class II
Class IID-0152-2021
Product
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01
- Brand name
- Heb
- Generic name
- Clotrimazole
- Active ingredient
- Clotrimazole
- Route
- Topical
- NDC
- 37808-305
- FDA application
- M005
- Affected lot / code info
- Lot#: A873630558 Dec-2020; D867331276, Exp Mar-2021
Why it was recalled
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- H E B
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- N/A
- Distribution pattern
- Distributed Nationwide in the USA and Canada
Timeline
- Recall initiated
- 2020-11-17
- FDA classified
- 2020-12-16
- Posted by FDA
- 2020-12-23
- Terminated
- 2024-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0152-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.