March 2017 FDA Recall Kalbitor by Shire
D-0625-2017 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Shire on March 17, 2017 for the product Kalbitor. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0625-2017

Reason for Recall
Presence of Particulate Matter: Glass
Initiated
03-17-2017
Reported
04-12-2017
Quantity
3, 536 cartons (3 vials per carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76761
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Shire
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Kuwait
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-25-2021
Product Description About Product Description
Full technical description of the product.
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01

Batch or Lot Expiration Information

Lot# : A1500009, Exp. Jan 31, 2019

Affected Packages Involved in this Recall

47783-101-01 Kalbitor