Taro Pharmaceuticals U.S.A., Inc.: Drug Recall

Recall #D-0727-2022 · 02/25/2022

Class III: Low Risk

Recall Details

Recall Number: D-0727-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc.
Status: Terminated
Date Initiated: 02/25/2022
Location: Hawthorne, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 768 tubes

Reason for Recall

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

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

Distribution Pattern

Product was distributed to one retail consignee in NY.

Other Recalls by Taro Pharmaceuticals U.S.A., Inc.

Class III: Low Risk 08/07/2024

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class I: Dangerous 12/15/2021

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II: Risk 01/08/2021

CGMP deviations.

View all recalls by Taro Pharmaceuticals U.S.A., Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.