FDA recall D-0151-2021

Taro Pharmaceuticals U.S.A., Inc. · Class II · drug

Product

Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.

Reason for recall

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Distribution

Distributed Nationwide in the USA and Canada

Key facts

Status
Terminated
Initiation date
2020-11-17
Report date
2020-12-23
Termination date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2021