PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 23, 2020 Initiated: November 17, 2020 #D-0153-2021

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%.

Details

Units Affected
30,816 1 oz tubes
Distribution
Distributed Nationwide in the USA and Canada
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 30,816 1 oz tubes.
Why was this product recalled?
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0153-2021.