Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distri...

FDA Recall #D-0155-2021 — Class II — November 17, 2020

Recall #D-0155-2021 Date: November 17, 2020 Classification: Class II Status: Terminated

Product Description

Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01

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

45,396 units

Distribution

Distributed Nationwide in the USA and Canada

Code Information

Lot#: A873630557, Exp Dec 2020 70,200 63,252

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated