Novo Nordisk Voluntarily Recalls Select Batches of Diabetes Kit

Novo Nordisk has implemented a voluntary recall of six batches of the GlucaGen HypoKit (glucagon [rDNA origin] for injection) in the US due to two customer complaints from the UK and Portugal involving detached needles on the syringe with sterile water for injection. GlucaGen HypoKit is indicated for treating severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.

Novo Nordisk has conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen HypoKit. Novo Nordisk is recalling affected batches from wholesalers, pharmacies  and patients in the US. It is estimated that out of the 71,215 pens being recalled, four pens could be defective. The affected products were distributed starting February 15, 2016.

Novo Nordisk said it is working as quickly as possible and in collaboration with the US Food and Drug Administration to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.

Source: FDA and Novo Nordisk

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