Notice on recall of the batch 14160 of Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin)
PharmaMar S.A., marketing authorisation holder for Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin), has notified the Agency for medicinal Products and Medical Devices (HALMED) on the recall of the batch 14160 of this medicine due to a discovered quality defect. The quality defect consists of a risk of foreign particles in vials. As a precaution measure, further distribution and use of this batch is stopped in all hospital settings in the Republic of Croatia, where this medicine is used.
The recall of this batch is being conducted at the hospital level.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.