PRA number
Published date
Product description
NovoMix 30 Penfill
ARTG 143165
(NovoMix 30 Penfill 3mL 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine 300U/3mL injection cartridge)
What are the defects?
The instructions inside the product has incorrect labelling:
- The customer medicine information has incomplete description of the active ingredient and its appearance.
- The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® 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 NovoMix® 30 Penfill® 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.’
What are the hazards?
The effects of exposure to protamine sulfate to users who are allergic to this ingredient or to fish, may result in a severe to life threatening allergic reaction.
What should consumers do?
Consumers should follow the instructions on the carton which indicate to keep the NovoMix® 30 Penfill® 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
Dates available for sale
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.