Arixtra Recall: Needle Iron Particle Discoloration in Pre-filled Syringes

BfArM published a Direct Healthcare Professional Communication regarding a quality defect in Viatris Healthcare Limited's Arixtra (fondaparinux sodium) pre-filled syringes. The defect involves brown discoloration and blockage in needles caused by oxidized iron particles. The recall affects pre-filled syringes that may contain extraneous iron particles in the needle assembly.

Healthcare providers and pharmacies should immediately quarantine and stop dispensing any Arixtra syringes showing discoloration at the needle base. Patients currently using Arixtra should be monitored, and any suspected adverse reactions related to iron particle contamination should be reported. This quality defect poses a risk to patient safety if contaminated product is administered.