D-0217-2017 Class I Terminated
FDA drug recall D-0217-2017 was initiated by Novo Nordisk Inc on Sep 8, 2016 and is designated Class I. Reason for recall: Defective delivery system: detached needles on the syringe in the kit. The recall status is terminated (terminated Feb 27, 2018). Affected quantity: 71,215 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 28, 2016
- Initiation Date
- Sep 8, 2016
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0217-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026