FDA recall D-0158-2021

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

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

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-0158-2021