FDA recall D-0432-2017

Shire PLC · Class III · drug

Product

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-12-02
Report date: 2017-01-25
Termination date: 2018-06-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2017