NovoMix 30 Penfill
AustraliaNovoMix 30 Penfill
Reason for Recall / Hazard
TranslatedThe instructions inside the product has incorrect labelling: The customer medicine information has incomplete description of the active ingredient and its appearance. The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® 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 NovoMix® 30 Penfill® 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
TranslatedReason / Defects: The instructions inside the product has incorrect labelling: The customer medicine information has incomplete description of the active ingredient and its appearance. The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® 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 NovoMix® 30 Penfill® 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: 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. What to do: 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.
Affected Products
TranslatedNovoMix 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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 960d5895-39e0-4284-ac67-124448e85a2c |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/novomix-30-penfill |
| Pub Date | Thu, 10 Feb 2022 00:00:00 +0000 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought NovoMix 30 Penfill?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Risk LevelPharmacy and medical products
- DistributionAustralia
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