Some GlucaGen HypoKits Recalled Over Hypoglycemia Risk

Disclosures

September 09, 2016

Reports of needles detached from the syringes of the GlucaGen HypoKit have prompted the manufacturer Novo Nordisk to voluntarily recall six batches of the glucagon-injecting devices in the United States because they might leave patients untreated for hypoglycemia, the US Food and Drug Administration (FDA) announced today.

The GlucaGen HypoKit is approved for severe hypoglycemia in patients with diabetes who use insulin. Untreated hypoglycemia can spiral into unconsciousness, seizures, and death.

Novo Nordisk received complaints from two customers in the United Kingdom and Portugal about detached needles, which renders the syringe unusable as prescribed, according a MedWatch alert from the FDA. A company investigation found that 0.006% of the needles could be detached from the syringe in batches of the GlucaGen HypoKit distributed since February 15, 2016. Novo Nordisk estimates that only four of the 71,215 devices being recalled in the United States are defective.

The recall covers the following batches of the device, all with an expiration date of September 30, 2017:

  • FS6X270

  • FS6X296

  • FS6X538

  • FS6X597

  • FS6X797

  • FS6X875

Patients or caregivers should check the batch number on their device, found on the top right-hand side of the box, to see if it matches one on the recall list.

More information on today's FDA MedWatch alert is available on the FDA website.

To report any problems with the GlucaGen HypoKit, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Follow Robert Lowes on Twitter @LowesRobert

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