Recall: D-1017-2018

Class II - Potentially Harmful

Class IIClassification

2018-07-18Initiated

TerminatedStatus

VENSUN PHARMACEUTICALS INCFirm

Product

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.

Reason

Failed Tablet/Capsule Specifications: Tablet breakage

Distribution

Within the United States and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.