Novo Nordisk Inc recalls GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo…

Recall date

September 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0217-2017

FDA classification

Class I

Brand / firm

Novo Nordisk Inc

Sold / distributed

Nationwide and Worldwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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