Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
FDA recall notice · announced October 20, 2021 · Strides Pharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Reason for recall
Failed Dissolution Specifications
Notes
Distribution: Nationwide
Lot/code information: Lot 7240840A, exp. 12/31/2021
Quantity: 1813 bottles
Status: Terminated
Products in this recall event:
- Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Bru (D-0006-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.