On September 9, 2016, Novo Nordisk Inc. recalled six batches of the GlucaGen HypoKit (glucagon [rDNA origin] for injection) 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).
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.
GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. 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. 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.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, May 2014 Report: Diabetes and Its Complications: Malpractice and Other Liability Issues
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication