Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured...
FDA Recall #D-0432-2017 — Class III — December 2, 2016
Product Description
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
Recalling Firm
Shire PLC — Lexington, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,520 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot Number AE7363A, exp 06/30/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated