Home / Recalls / Strides Pharma Science Limited / D-1029-2020

D-1029-2020 Class III Terminated

Recalled by Strides Pharma Science Limited — Bangalore

Recall Details

Product Type: Drugs
Report Date: March 25, 2020
Initiation Date: February 17, 2020
Termination Date: February 16, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2576 bottles

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.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021