NovoRapid FlexPen
Reason for Recall / Hazard
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.’
Product Description & Identification
Reason / Defects: 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.’ Hazards: Storing the product at incorrect temperatures may result in reduced effectiveness, which may increase the risk of adverse health effects. What to 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.
Affected Products
NovoRapid FlexPen ARTG 133445 (NovoRapid FlexPen insulin aspart (rys) 300U/3mL injection multidose cartridge)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | ef9e01dc-034b-4fe0-ab7a-e66781d39128 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/novorapid-flexpen |
| Pub Date | Thu, 10 Feb 2022 00:00:00 +0000 |