Fiasp FlexTouch
Published 10 February 2022
Product
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
Why it was recalled
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.’
Hazard
Storing the product at incorrect temperatures may result in reduced effectiveness, which may increase the risk of adverse health effects.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.