FDA-Drug2018-08-08Class II

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

VENSUN PHARMACEUTICALS INC
Hazard

Failed Tablet/Capsule Specifications: Tablet breakage

Sold states
Within the United States and Puerto Rico.
Affected count
11,652 bottles
Manufactured in
790 Township Line Rd, N/A, Yardley, PA, United States
Products
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1017-2018

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