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D-0625-2017 Class II Terminated

Recalled by Shire — Lexington, MA

FDA drug recall D-0625-2017 was initiated by Shire on March 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: April 12, 2017
Initiation Date: March 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