Home / Recalls / Shire PLC / D-0432-2017

D-0432-2017 Class III Terminated

Recalled by Shire PLC — Lexington, MA

FDA drug recall D-0432-2017 was initiated by Shire PLC on Dec 2, 2016 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules The recall status is terminated (terminated Jun 1, 2018). Affected quantity: 4,520 bottles.

Recall details

Product Type: Drugs
Report Date: Jan 25, 2017
Initiation Date: Dec 2, 2016
Termination Date: Jun 1, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,520 bottles

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

Distribution pattern

Nationwide and Puerto Rico

Code information

Lot Number AE7363A, exp 06/30/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0432-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.