FDA recall D-0217-2017

Novo Nordisk Inc · Class I · drug

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

Reason for recall

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

Distribution

Nationwide and Worldwide

Key facts

Status: Terminated
Initiation date: 2016-09-08
Report date: 2016-12-28
Termination date: 2018-02-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plainsboro, NJ, United States

Primary source

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