FDA-Drug2017-01-25Class III
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Shire PLC
Hazard
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Sold states
Nationwide and Puerto Rico
Affected count
4,520 bottles
Manufactured in
300 Shire Way, Lexington, MA, United States
Products
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2017Don't want to check this manually?
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