Novo Nordisk Recalls GlucaGen HypoKit

September 12, 2016

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

On Sept. 8, 2016, Novo Nordisk announced that it was voluntarily recalling six batches of the GlucaGen HypoKit in the United States because of customer complaints of detached needles on the syringe included in the kits. The affected products were distributed starting February 15, 2016.

The customer complaints came from the United Kingdom and Portugal and involved detached needles on the syringe with Sterile Water for Injection (SWFI), rendering the product unable to be used as prescribed. A company investigation found that a small number of needles could be detached from the syringe in certain batches. The batches are being recalled to product patient safety, and the company estimates that 4 out of 71,215 pens may be defective. The recalled batch numbers are as follows:

  • Batch: FS6X270, Expiry: 09/30/2017

  • Batch: FS6X296, Expiry: 09/30/2017

  • Batch: FS6X538, Expiry: 09/30/2017

  • Batch: FS6X597, Expiry: 09/30/2017

  • Batch: FS6X797, Expiry: 09/30/2017

  • Batch: FS6X875, Expiry: 09/30/2017

According to Novo Nordisk, GlucaGen HypoKit is used for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. If left untreated, hypoglycemia can lead to unconsciousness and seizures as well as a decline in brain glucose levels. A decline in brain glucose can cause cognitive dysfunction, sweating, tremors, convulsion, and eventually coma or death.

Source: FDA