Novo Nordisk Issues Nationwide Recall of Six Batches of GlucaGen HypoKit Due to Detached Needles on the Syringe
Product is prescribed for the treatment of low blood sugar diabetes patients
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 prescribed for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin.
Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. A syringe with a detached needle cannot be used as prescribed.
Novo Nordisk conducted an investigation which showed that a small number (0.006 percent) 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.
This recall includes GlucaGen HypoKit batch numbers FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, and FS6X875. All recalled batch numbers have an expiry date of 09/30/2017.
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 in the accompanying image.
The affected products were distributed starting February 15, 2016.
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.
The company is also notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.
If you are in possession of a GlucaGen HypoKit with a batch number NOT< mentioned above, the product is not subject to the recall and may be used as prescribed.
To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.
If you have a GlucaGen HypoKit with one of the above-mentioned batch numbers, call customer service at (888) 840-1137 to find out how to return the product. Novo Nordisk will provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen HypoKit with proof of purchase. If you received a GlucaGen HypoKit through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.
Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling (800) 727-6500.