GlucaGen HypoKit
The marketing authorization holder has informed its customers as well as pharmacies, institutional pharmacies, physicians in private practice and patient organizations by letter dated 06.09.2016 that there is a possibility of a detached needle from the syringe in the above mentioned batch of GlucaGen HypoKit. During investigations based on two complaints, it was found that a very small number of needles (0.006%) were detached from the syringes in certain batches of GlucaGen HypoKit. This drug product is used to treat severe hypoglycemic reactions that can occur during insulin therapy in children and adults with diabetes mellitus. A GlucaGen HypoKit with a detached needle can be used in the event of a hypoglycemic episode. cannot be used as prescribed in the event of a hypoglycemic episode, therefore the affected lot is being recalled.
| Name of the medicinal product | GlucaGen HypoKit 1 mg/ml - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | 1 - 24626 |
| Marketing authorisation holder | Novo Nordisk Pharma GmbH |
| Batch number(s) | FS6X569 |
| Classification of the recall | 1 |
| BASG reference number | INS - 640.001 - 1818 |
