FDA recall D-1029-2020

Product

Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08

Reason for recall

Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-02-17

Report date

2020-03-25

Termination date

2021-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bangalore, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1029-2020