TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14...

FDA Recall #D-0158-2021 — Class II — November 17, 2020

Recall #D-0158-2021 Date: November 17, 2020 Classification: Class II Status: Terminated

Product Description

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%.

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

N/A

Distribution

Distributed Nationwide in the USA and Canada

Code Information

Lot#: D867331277, Exp Mar 2021 70,200 63,252

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated