Strides Pharma Inc.: Drug Recall

Recall #D-0006-2022 · 09/27/2021

Class II: Risk

Recall Details

Recall Number: D-0006-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Strides Pharma Inc.
Status: Terminated
Date Initiated: 09/27/2021
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1813 bottles

Reason for Recall

Failed Dissolution Specifications

Product Description

Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.

Distribution Pattern

Nationwide

Other Recalls by Strides Pharma Inc.

Class II: Risk 07/09/2025

Failed Dissolution Specifications.
Class II: Risk 03/05/2025

Presence of foreign substance: Presence of Benzene.
Class II: Risk 03/05/2025

Presence of foreign substance: Presence of Benzene.
Class II: Risk 12/29/2023

Failed Dissolution Specifications
Class II: Risk 06/26/2023

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

View all recalls by Strides Pharma 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.