Drug recall D-1029-2020

Class III Terminated reported Mar 25, 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.

Lots and codes

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

Recall details

Recalling firm
Strides Pharma Science Limited, Bangalore
Quantity
2576 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 17, 2020
Terminated
February 16, 2021

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