US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 17, 2017 (9 years ago)

Kalbitor

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Particulate Matter: Glass

What was recalled

Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01

Recalling firm
Shire
NDC code
47783-101-01
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0625-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.