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.