Novo Nordisk is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI).
GlucaGen HypoKit is indicated for the treatment of 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.
Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.
Novo Nordisk 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®.
To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the U.S. It is estimated that out of the 71,215 pens being recalled, four pens could be defective.
Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) 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.
Patients or caregivers should check the batch number to see if their GlucaGen® HypoKit® is affected. The batch number is printed on the GlucaGen® HypoKit® as indicated below in the red box (Figure 1).
Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Novo Nordisk is committed to patient safety and delivering high-quality medicines, and is working to take corrective actions and avoid re-occurrence.