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Recall Observatory FDA recall evidence

Drug product

Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.

D-0151-2021

November 17, 2020

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 86833
Status
Terminated
Classification
Class II
Quantity
481,896 tubes
Official record key
drug-enforcement:D-0151-2021

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#: a)A873430371, Exp Dec-2020; B870030918, Exp Jan-2021; C868330918, Exp Feb-2021 b) A873430406, A873530406, A873630406, Exp Dec-2020;B870030635, B870130867, Exp Jan-2021; C868330867, Exp Feb-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