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

Recall #D-0633-2024 · 08/07/2024

Class III: Low Risk

Recall Details

Recall Number: D-0633-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc.
Status: Completed
Date Initiated: 08/07/2024
Location: Hawthorne, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 96 vials

Reason for Recall

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.

Product Description

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01

Distribution Pattern

Product was distributed to one distributor

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

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 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.