Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81

Recall Number: D-0432-2017

Firm: Shire PLC

Classification: Class III

Status: Terminated

Report Date: 20170125

Initiation Date: 20161202

Termination Date: 20180601

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81