FDA recall D-0001-2021

Strides Inc. · Class II · drug

Product

Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06

Reason for recall

Failed Dissolution Specifications

Distribution

nationwide

Key facts

Status: Terminated
Initiation date: 2020-08-24
Report date: 2020-10-07
Termination date: 2022-01-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lambertville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2021