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
Recall initiated: 20161202
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated