Recall Initiated for Antihypoglycemic Agent
Novo Nordisk announced a recall of six batches of the GlucaGen HypoKit (glucagon [rDNA origin] for injection) in the U.S. due to two customer complaints (in the U.K. and Portugal) involving detached needles on the syringe with Sterile Water for Injection. GlucaGen HypoKit is used for the treatment of severe hypoglycemia in patients with diabetes who are treated with insulin.
The investigation shows that a small number of needles could be detached from the syringe in certain batches; a syringe with a detached needle cannot be used as prescribed. It is estimated that out of the 71,215 pens being recalled, four pens may be defective. The affected batch numbers include:
- 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
These products were distributed beginning February 15, 2016, however, to date, the company is not aware of any adverse events resulting from the use of the recalled batches.
Novo Nordisk asks that patients in position of the recalled product call 1-888-840-1137 to find out how to return the product. Adverse reactions or quality problems experienced with the use of this product may be reported to the company by calling 1-800-727-6500. In addition adverse events can be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting program.
For more information visit NovoNordisk-US.com.