D-0153-2021 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
November 17, 2020
Termination Date
February 21, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,816 1 oz tubes

Product Description

Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30

Reason for Recall

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Distribution Pattern

Distributed Nationwide in the USA and Canada

Code Information

Lot#: A873630634, Exp Dec 2020; B870030634, Exp, Jan 2021