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

See a list of details to help identify the product

Reason 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.

Details to help identify the product

Supplier running the recall

Novo Nordisk Pharmaceuticals Pty Ltd

Who sold the product

Pharmacies and health care providers.

Where the product was sold

Nationally

Responsible regulators

Regulators are established or appointed by government. They enforce regulations and rules.

Quote PRA number 2016/15629 when contacting a regulator about this recall.

Recall and remedy questions

Contact the Therapeutic Goods Administration if you have:

  • a question about the remedy being offered to you by the business that is responsible for managing this recall, or
  • concerns about the way the business is managing this recall.