Recalls / Class II
Class IID-0155-2021
Product
Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
- Brand name
- Kroger
- Generic name
- Clotrimazole
- Active ingredient
- Clotrimazole
- Route
- Topical
- NDC
- 30142-510
- FDA application
- M005
- Affected lot / code info
- Lot#: A873630557, Exp Dec 2020 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
- Kroger Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 45,396 units
- 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-0155-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.