Shire recalls Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Recall date
- March 17, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0625-2017
- FDA classification
- Class II
- Brand / firm
- Shire
- Sold / distributed
- Nationwide and Kuwait
Why it was recalled
Presence of Particulate Matter: Glass
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
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