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Novo Nordisk recalls six batches of GlucaGen HypoKit
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Novo Nordisk is voluntarily recalling six batches of the GlucaGen HypoKit in the United States due to two customer complaints from the United Kingdom and Portugal involving detached needles on the syringe with Sterile Water for Injection, according to the FDA.
The GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia in patients with diabetes treated with insulin. A syringe with a detached needle cannot be used as prescribed.
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 United States. It is estimated that out of the 71,215 pens being recalled, four pens could be defective.
This recall includes GlucaGen HypoKit batch numbers:- Batch: FS6X270; Expires: 09/30/2017
- Batch: FS6X296; Expires: 09/30/2017
- Batch: FS6X538; Expires: 09/30/2017
- Batch: FS6X597; Expires: 09/30/2017
- Batch: FS6X797; Expires: 09/30/2017
- Batch: FS6X875; Expires: 09/30/2017
The affected products were distributed starting Feb. 15, 2016.
To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches, according to the FDA.
Patients or caregivers with an affected kit should call 1-888-840-1137 from Monday to Friday, between 8:30 a.m. and 6 p.m. Eastern, to find out how to return the product. Novo Nordisk will provide reimbursement for out-of-pocket costs incurred with proof of purchase.
Novo Nordisk Inc. is notifying its distributors and customers by letter and phone and is arranging for return of all recalled products.
Adverse reactions or quality problems experienced with the use of this product may be reported to Novo Nordisk by calling 1-800-727-6500.