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

Recall #D-0246-2021 · 01/08/2021

Class II: Risk

Recall Details

Recall Number: D-0246-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc.
Status: Terminated
Date Initiated: 01/08/2021
Location: Hawthorne, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44,256 bottles

Reason for Recall

CGMP deviations.

Product Description

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1

Distribution Pattern

Nationwide

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 I: Dangerous 12/15/2021

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

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.