PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 20, 2021 Initiated: September 27, 2021 #D-0006-2022

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.

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Strides Pharma Inc.
Units Affected
1813 bottles
Distribution
Nationwide
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Strides Pharma Inc.. Units affected: 1813 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on October 20, 2021. Severity: Moderate. Recall number: D-0006-2022.