FDA-Drug2021-10-20Class II

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.

Strides Pharma Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
1813 bottles
Manufactured in
2 Tower Center Blvd Ste 1102, N/A, East Brunswick, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2022

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