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

Recall #D-0375-2022 · 12/15/2021

Class I: Dangerous

Recall Details

Recall Number: D-0375-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc.
Status: Terminated
Date Initiated: 12/15/2021
Location: Hawthorne, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 96 tubes

Reason for Recall

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Product Description

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3

Distribution Pattern

Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.

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 III: Low Risk 02/25/2022

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