Exact FDA event identifier

Event 75123

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 08, 2016
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Novo Nordisk Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-0217-2017
Initiated: September 08, 2016
Classification: Class I
Status: Terminated
Recalling firm: Novo Nordisk Inc
Quantity: 71,215 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective delivery system: detached needles on the syringe in the kit.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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