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Arixtra Quality Defect: Needle Discoloration and Iron Particle

Favicon for www.bfarm.de BfArM Drug Safety Communications
Published February 6th, 2026
Detected March 13th, 2026
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Summary

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a notice regarding a quality defect in Arixtra pre-filled syringes. Reports indicate brown discoloration and needle blockage due to oxidized iron particles, posing a risk to patients. Healthcare professionals are instructed not to dispense or administer affected products.

What changed

Viatris Healthcare Limited has informed healthcare professionals of a serious quality defect affecting Arixtra pre-filled syringes. The defect involves brown discoloration and blockage in the needle, caused by an extraneous iron particle that has oxidized. This issue necessitates immediate action to prevent administration of potentially compromised medication.

Healthcare providers are instructed not to dispense or administer Arixtra if the needle base in the pre-filled syringe shows discoloration. This direct healthcare professional communication highlights the critical need for vigilance in product inspection and administration to ensure patient safety and prevent adverse events related to the defective needles.

What to do next

  1. Do not dispense or administer Arixtra if the needle base is discolored.

Source document (simplified)

Direct Healthcare Professional Communication (DHPC) on Arixtra: Serious quality defect related to the needle in pre-filled syringe

2026.02.06

Active substance: fondaparinux sodium

The company Viatris Healthcare Limited informs about reports of brown discoloration and blockage in the needle of Arixtra pre-filled syringes, which is related to the presence of an extraneous iron particle inside the needle which has oxidized. If the needle base in the pre-filled syringe is discolored, do not dispense or administer Arixtra.

Download DHPC/Information letter, DownloadVeroeffentlichtAmEN

2026.02.06

PDF, 722KB, File does not meet accessibility standards

Classification

Agency
Various
Published
February 6th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Healthcare providers Pharmaceutical companies
Geographic scope
National (Germany)

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Product Safety Pharmaceuticals

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