D-0217-2017 Class I Terminated

Recalled by Novo Nordisk Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
December 28, 2016
Initiation Date
September 8, 2016
Termination Date
February 27, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
71,215 kits

Product Description

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

Reason for Recall

Defective delivery system: detached needles on the syringe in the kit.

Distribution Pattern

Nationwide and Worldwide

Code Information

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