September 2016 FDA Recall Drug by Novo Nordisk Inc
D-0217-2017 - Defective delivery system

This Class I drug recall was voluntarily initiated by Novo Nordisk Inc on September 8, 2016 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0217-2017

Reason for Recall
Defective delivery system: detached needles on the syringe in the kit.
Initiated
09-08-2016
Reported
12-28-2016
Quantity
71,215 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75123
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novo Nordisk Inc
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Worldwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2018
Product Description About Product Description
Full technical description of the product.
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15

Batch or Lot Expiration Information

Lot# Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017