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Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured...

FDA Recall #D-0153-2021 — Class II — November 17, 2020

Recall #D-0153-2021 Date: November 17, 2020 Classification: Class II Status: Terminated

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%.

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

30,816 1 oz tubes

Distribution

Distributed Nationwide in the USA and Canada

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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