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NovoMix 30 Penfill

Official notice

10 Feb 2022

Last checked

10 Feb 2022

Medium riskACCC

An official ACCC notice concerns NovoMix 30 Penfill. 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. Published 2022-02-10.

What to do now

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.

Recall number

960d5895-39e0-4284-ac67-124448e85a2c

Official notice

2022-02-10

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

143165

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Affected products

Product 1

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)

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

medium

Recall details

Recall number

960d5895-39e0-4284-ac67-124448e85a2c

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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