FDA-Drug2016-12-28Class I

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

Novo Nordisk Inc
Hazard

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

Sold states
Nationwide and Worldwide
Affected count
71,215 kits
Manufactured in
800 Scudders Mill Road, N/A, Plainsboro, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2017

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