Novo Nordisk Pharmaceuticals Pty Ltd — NovoRapid FlexPen

PRA number

2021/19260

Published date

Product description

NovoRapid FlexPen

ARTG 133445

(NovoRapid FlexPen insulin aspart (rys) 300U/3mL injection multidose cartridge)

Identifying features

Barcode number

9324627001297

Reasons the product is recalled

The storage instructions inside the product has incorrect labelling. The pack insert incorrectly states:

  • ‘Do not keep the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you.  

The storage conditions are correctly stated on the product carton. The correct statement reads:

  • ‘You can carry the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’

The hazards to consumers

Storing the product at incorrect temperatures may result in reduced effectiveness, which may increase the risk of adverse health effects.

What consumers should do

Consumers should follow the instructions on the carton which indicate to keep the NovoRapid® FlexPen® they are using, or carrying as a spare, either below 30°C or in a refrigerator (2°C - 8°C).

Consumers can obtain a current Consumer Medicine Information leaflet from a pharmacist or visit the TGA website at https://www.ebs.tga.gov.au/

For further information, contact NovoNordisk Customer Service by phone on 1800 668 626.

Traders who sold this product

Pharmacies and distributors 

Where the product was sold

Nationally

Dates available for sale

-

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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