FDAClass IIIMarch 25, 2020

Potassium Chloride Extended-Release Tablets USP recall

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

Why was Potassium Chloride Extended-Release Tablets USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Strides Pharma Science Limited
Quantity
2576 bottles
Distribution
U.S.A. Nationwide
Recall date
March 25, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls