Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Le…

Recall date

December 2, 2016

Source

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

Recall number

D-0432-2017

FDA classification

Class III

Brand / firm

Shire PLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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