Strides Pharma Science Limited recalls Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Sh…

Recall date

February 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1029-2020

FDA classification

Class III

Brand / firm

Strides Pharma Science Limited

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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