Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distribu...

FDA Recall #D-0159-2021 — Class II — November 17, 2020

Recall #D-0159-2021 Date: November 17, 2020 Classification: Class II Status: Terminated

Product Description

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%.

Recalling Firm

Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

40,896 1 oz tube

Distribution

Distributed Nationwide in the USA and Canada

Code Information

Lot#: B870130838, Exp Jan 2021 70,200 63,252

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated