FDA recall D-0006-2022

Strides Pharma Inc. · Class II · drug

Product

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2021-09-27
Report date: 2021-10-20
Termination date: 2022-10-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2022