Pentasa Capsule
FDA Recall NDC 54092-191
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pentasa (NDC 54092-191). A significant event, classified as Class III, was initiated on Dec 02, 2016 by Takeda Pharmaceuticals America, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2016 Class III Recall: Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Recall Number
Class III Terminated
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Dec 02, 2016
Jan 25, 2017
4,520 bottles
Recall Profile & Regulatory Data
Event ID
75880
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Shire PLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 01, 2018
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
Batch or Lot Expiration Information
Lot# Lot Number AE7363A, exp 06/30/2019
Affected Packages Involved in this Recall
54092-189-81Product
54092-191-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
