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Recall Observatory FDA recall evidence

Drug product

TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2

D-0158-2021

November 17, 2020

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 86833
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0158-2021

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#: D867331277, Exp Mar 2021 70,200 63,252

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