PRA number
2016/15629
Published date
Product description
Powder vial containing glucagon 1mg (1IU) as hydrochloride and lactose monohydrate 107mg, for injection, used for the treatment of severe low blood sugar, which may occur in the management of patients with diabetes receiving insulin or oral hypoglycaemic agents. Solvent syringe contains 1mL water for injection.
AUST R 47105
AUST R 47105
Reasons the product is recalled
Possibility of injection needle detaching from 1mL pre-filled solvent syringe.
The hazards to consumers
Detachment of the injection needle from the pre-filled solvent syringe would prevent injection of the medicine.
What consumers should do
Patients with diabetes or their carers should check the batch numbers on their GlucaGen HypoKit.
If you have products from the affected batches, you should return it to your pharmacy. You will be provided with a free replacement kit immediately if your pharmacy has stock, or within a few days if the pharmacy needs to restock.
If you cannot receive a replacement immediately, you can retain your GlucaGen HypoKit until a replacement can be provided, as the likelihood of a detached needle is very low.
Additional information can be obtained from Novo Nordisk by calling the Novocare Customer Care Centre on 1800 668 626.
Supplier
Novo Nordisk Pharmaceuticals Pty Ltd
Traders who sold this product
Pharmacies and health care providers.
Where the product was sold
Nationally
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.