Novo Nordisk Pharmaceuticals Pty Ltd — GlucaGen HypoKit Glucagon (rys)

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
Photograph of GlucaGen HypoKit

What are the defects?

Possibility of injection needle detaching from 1mL pre-filled solvent syringe.

What are the hazards?

Detachment of the injection needle from the pre-filled solvent syringe would prevent injection of the medicine.

What should consumers 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

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category