PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: March 25, 2020 Initiated: February 17, 2020 #D-1029-2020

Product Description

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.

Details

Units Affected
2576 bottles
Distribution
U.S.A. Nationwide
Location
Bangalore

Frequently Asked Questions

What product 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. Recalled by Strides Pharma Science Limited. Units affected: 2576 bottles.
Why was this product recalled?
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 25, 2020. Severity: Low. Recall number: D-1029-2020.