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
D-0217-2017
Product summary
- Firm
- Novo Nordisk Inc
- Event
- Event 75123
- Status
- Terminated
- Classification
- Class I
- Quantity
- 71,215 kits
- Official record key
drug-enforcement:D-0217-2017
Official wording
Reason: Defective delivery system: detached needles on the syringe in the kit.
Code information: Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017
Distribution pattern: Nationwide and Worldwide
Derived failure modes
-
Unknown
Defective delivery system: detached needles on the syringe in the kit.