D-0156-2021 Class II Terminated

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

FDA drug recall D-0156-2021 was initiated by Taro Pharmaceuticals U.S.A., Inc. on November 17, 2020 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. The recall status is terminated (terminated February 21, 2024). Affected quantity: 34,920 0.5 oz tubes.

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
34,920 0.5 oz tubes

Product Description

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 Pattern

Distributed Nationwide in the USA and Canada

Code Information

Lot#: A873630559, Exp Dec 2020.