OECDReference EN/AU/PS1096549
NovoRapid FlexPen
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- NovoRapid FlexPen
- Official identifiers
- EAN: 9324627001297
Official information
Risk and measures
- Risk or 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.’ Storing the product at incorrect temperatures may result in reduced effectiveness, which may increase the risk of adverse health effects.
- Recommendations
- 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.
Official information
Economic operators
- Manufacturer
- Novo Nordisk Pharmaceuticals Pty Ltd
Territory
Geography
- Origin
- Brazil
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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