Novo Nordisk Pharmaceuticals Pty Ltd — Fiasp FlexTouch

PRA number

2021/19259

Published date

Product description

Fiasp FlexTouch

ARTG 275394

(Fiasp FlexTouch insulin aspart (rys) 100 units/mL solution for injection 3mL pre-filled pen)

Batch numbers:
LP58119 expiry date 30/09/2023
LP58452 expiry date 30/09/2023

Identifying features

Barcode number

9324627002119

What are the defects?

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

  • ‘Do not keep the Fiasp® FlexTouch® 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 Fiasp® FlexTouch® 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?

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

What should consumers do?

Consumers should follow the instructions on the carton which indicate you can carry the Fiasp® FlexTouch® you 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