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Recall Observatory FDA recall evidence

Drug product

Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01

D-0154-2021

November 17, 2020

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 86833
Status
Terminated
Classification
Class II
Quantity
133,452 0.5 oz tubes
Official record key
drug-enforcement:D-0154-2021

Official wording

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

Code information: Lot#: A873430372, Exp Dec 2020; D867331278, Exp Mar 2021

Distribution pattern: Distributed Nationwide in the USA and Canada

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications