FDA Recall D-0217-2017
Novo Nordisk Inc · Plainsboro, NJ
Class I — life-threatening Terminated 537 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0217-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and Worldwide
- Recall initiated
- 2016-09-08
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2018-02-27
- Recalling firm
- Novo Nordisk Inc
- Firm location
- Plainsboro, NJ