D-0217-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- September 8, 2016
- Termination Date
- February 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,215 kits
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.
Distribution Pattern
Nationwide and Worldwide
Code Information
Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017