GlucaGen HypoKit — Class I drug recall D-0217-2017
Terminated recall by Novo Nordisk Inc, reported 2016-12-28, distributed nationwide. Defective delivery system: detached needles on the syringe in the kit.
| Recall number | D-0217-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novo Nordisk Inc, Plainsboro, NJ, United States |
| Recall initiated | 2016-09-08 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 71,215 kits |
| Reason classes | device malfunction |
| NDC | 00169-7065-15 |
| Lot numbers | FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875 |
| Expiration dates | 2017-09-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0217-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.