FDA recall D-0156-2021

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

Product

RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1

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-0156-2021