Reported Apr 12, 2017 · Terminated
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Shire
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shire · 300-400 Shire Way · Lexington, MA · 02421-2101
Is this the product you have?
- Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Lot codes and dates
Lot #: A1500009Exp. Jan 312019
- Amount recalled
- 3, 536 cartons (3 vials per carton)
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Glass
This product could cause temporary or reversible health problems — stop using it.
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