FDA recall D-1018-2018

Product

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

Distribution

Within the United States and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2018-07-18

Report date

2018-08-08

Termination date

2019-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Yardley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1018-2018