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

FDA recall notice · announced April 12, 2017 · Shire

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Presence of Particulate Matter: Glass

Notes

Distribution: Nationwide and Kuwait
Lot/code information: Lot #: A1500009, Exp. Jan 31, 2019
Quantity: 3, 536 cartons (3 vials per carton)
Status: Terminated
Products in this recall event:
- Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 (D-0625-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.