Home / Recalls / Shire / D-0625-2017

D-0625-2017 Class II Terminated

Recalled by Shire — Lexington, MA

FDA drug recall D-0625-2017 was initiated by Shire on Mar 17, 2017 and is designated Class II. Reason for recall: Presence of Particulate Matter: Glass The recall status is terminated (terminated May 25, 2021). Affected quantity: 3, 536 cartons (3 vials per carton).

Recall details

Product Type: Drugs
Report Date: Apr 12, 2017
Initiation Date: Mar 17, 2017
Termination Date: May 25, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3, 536 cartons (3 vials per carton)

Product description

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

Distribution pattern

Nationwide and Kuwait

Code information

Lot #: A1500009, Exp. Jan 31, 2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0625-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.