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Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured...

FDA Recall #D-0727-2022 — Class III — February 25, 2022

Recall #D-0727-2022 Date: February 25, 2022 Classification: Class III Status: Terminated

Product Description

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

Reason for Recall

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Recalling Firm

Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

768 tubes

Distribution

Product was distributed to one retail consignee in NY.

Code Information

Lot #: AC33883, Exp. Date June 2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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