Published on 2026-01-28, a critical medical device alert has been issued for Arixtra solution for injection pre-filled syringes due to reports of brown discolouration and blockage in the needle, related to oxidation of the syringe needle.
Navigation: What changed? | Who is affected? | FAQ | Conclusion | Disclaimer
What changed?
Viatris Products Ltd has received reports of a quality defect in Arixtra solution for injection pre-filled syringes, specifically brown discolouration and blockage in the needle of the pre-filled syringes.
Root Cause
The defect is attributed to the oxidation of the syringe needle, which can potentially impact the safety and efficacy of the product.
Who is affected?
Clinical, quality, and regulatory teams, as well as healthcare professionals and patients using Arixtra solution for injection pre-filled syringes, should be aware of this defect notification.
Actions Required
It is essential for affected parties to take immediate action to mitigate any potential risks associated with the use of these defective pre-filled syringes.
FAQ
- What is the nature of the defect in Arixtra solution for injection pre-filled syringes?
The defect is characterized by brown discolouration and blockage in the needle of the pre-filled syringes. - What is the root cause of the defect?
The defect is attributed to the oxidation of the syringe needle. - Who should be aware of this defect notification?
Clinical, quality, and regulatory teams, as well as healthcare professionals and patients using Arixtra solution for injection pre-filled syringes.
Conclusion
In conclusion, the defect notification for Arixtra solution for injection pre-filled syringes is a critical alert that requires immediate attention from all stakeholders.
Disclaimer
This information is not intended to be legal advice. Healthcare professionals and regulatory teams should consult the original source and relevant authorities for comprehensive guidance.
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-viatris-products-ltd-arixtra-solution-for-injection-pre-filled-syringes-el-26-a-slash-04