PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: December 28, 2016 Initiated: September 8, 2016 #D-0217-2017

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.

Details

Recalling Firm
Novo Nordisk Inc
Units Affected
71,215 kits
Distribution
Nationwide and Worldwide
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Novo Nordisk Inc. Units affected: 71,215 kits.
Why was this product recalled?
Defective delivery system: detached needles on the syringe in the kit.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0217-2017.