Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2...
FDA Recall #D-0151-2021 — Class II — November 17, 2020
Product Description
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
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
481,896 tubes
Distribution
Distributed Nationwide in the USA and Canada
Code Information
Lot#: a)A873430371, Exp Dec-2020; B870030918, Exp Jan-2021; C868330918, Exp Feb-2021 b) A873430406, A873530406, A873630406, Exp Dec-2020;B870030635, B870130867, Exp Jan-2021; C868330867, Exp Feb-2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated