Recalls / Class II
Class IID-0158-2021
Product
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
- Brand name
- Topcare
- Generic name
- Clotrimazole
- Active ingredient
- Clotrimazole
- Route
- Topical
- NDC
- 36800-495
- FDA application
- M005
- Affected lot / code info
- Lot#: D867331277, Exp Mar 2021 70,200 63,252
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
- Topco Associates LLC
- 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-0158-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.