VENSUN PHARMACEUTICALS INC recalls Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceu…

Recall date

July 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1017-2018

FDA classification

Class II

Brand / firm

VENSUN PHARMACEUTICALS INC

Sold / distributed

Within the United States and Puerto Rico.

Why it was recalled

Failed Tablet/Capsule Specifications: Tablet breakage

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.