Arixtra (fondaparinux sodium): serious quality defect related to the needle in pre-filled syringe.

Summary:

• Viatris has received reports of brown discoloration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to the presence of an extraneous iron particle inside the needle which has oxidized.
• While the defect is estimated to be very rare, it can randomly occur among the batches currently distributed on the market and can potentially impact all presentations of Arixtra.
• Follow the below handling precautions before dispensing or administering Arixtra:
  • Carefully inspect all Arixtra pre-filled syringes for discoloration at the needle base;
  • If the needle base in the pre-filled syringe is discolored (as illustrated in Figure 1), do not dispense or administer Arixtra; instead, return it to the wholesaler and/or Viatris for a replacement. 
• Inform patients and caregivers of this quality defect and advise them on the handling precautions, including the requirement to return any units in which they observe the quality defect.

Published on: 06 February 2026