Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc.,
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Recall notice
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
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Source Page by GovInfoNow · govinfonow.com/recall/42141-shire-plc-recalls-pentasa-mesalamine-controlled-release-capsules-250-mg · Recall date December 2, 2016 · FDA enforcement record: FDA #D-0432-2017
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“Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc.,.” GovInfoNow, recall dated December 2, 2016. https://govinfonow.com/recall/42141-shire-plc-recalls-pentasa-mesalamine-controlled-release-capsules-250-mg. Based on FDA recall #D-0432-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0432-2017%22&limit=1).
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We’ve drafted a message you can send Shire PLC to request your refund or repair — edit it as you like.
Subject: Recall D-0432-2017 — Shire PLC Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bot Hello, I own a Shire PLC recalls Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., that is covered by recall D-0432-2017 from Shire PLC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0432-2017 (December 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0432-2017 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.