PlainRecalls
FDA Drug Moderate Class II Terminated

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.

Reported: August 8, 2018 Initiated: July 18, 2018 #D-1018-2018

Product Description

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.

Reason for Recall

Failed Tablet/Capsule Specifications: Tablet breakage

Details

Units Affected
3,683 bottles
Distribution
Within the United States and Puerto Rico.
Location
Yardley, PA

Frequently Asked Questions

What product was recalled?
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.. Recalled by VENSUN PHARMACEUTICALS INC. Units affected: 3,683 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Tablet breakage
Which agency issued this recall?
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1018-2018.