Shire recalls Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Presence of Particulate Matter: Glass
Recall notice
Presence of Particulate Matter: Glass
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Source Page by GovInfoNow · govinfonow.com/recall/41807-shire-recalls-kalbitor-ecallantide-10mg-ml-packaged-in-3-vials · Recall date March 17, 2017 · FDA enforcement record: FDA #D-0625-2017
Cite this page
“Shire recalls Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01.” GovInfoNow, recall dated March 17, 2017. https://govinfonow.com/recall/41807-shire-recalls-kalbitor-ecallantide-10mg-ml-packaged-in-3-vials. Based on FDA recall #D-0625-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0625-2017%22&limit=1).
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We’ve drafted a message you can send Shire to request your refund or repair — edit it as you like.
Subject: Recall D-0625-2017 — Shire Shire recalls Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Hello, I own a Shire recalls Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 that is covered by recall D-0625-2017 from Shire. 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-0625-2017 (March 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0625-2017 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.