Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lex
Recalled January 25, 2017 · FDA recall D-0432-2017 · Shire
Hazard
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules · FDA Class III
Units
4,520 bottles
Sold at
Nationwide and Puerto Rico
Description
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Product
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Manufacturer(s)
Shire PLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →