FDA recall D-0159-2021

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

Product

Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0

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-0159-2021