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)
See a list of details to help identify the product
Reason the product is recalled
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.’
The hazards to consumers
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 consumers should 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.
Details to help identify the product
Supplier running the recall
Who sold the product
Pharmacies and distributors
Identifying product features
Identifying numbers
Barcode number
Dates available for sale
Where the product was sold
Manufacturer country ID
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2021/19261 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.