Information about recall of the batch 0380313 of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel)
Pliva Croatia d.o.o., the marketing authorisation for Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel), has informed the Agency for Medicinal Products and Medical Devices (HALMED) abot the decision to recall the batch 0380313 of this medicinal product due to a quality defect. The quality defect was discovered during stability studies at 25°C/60%RH, after 12 months, where the obtained result was out of specification for the parameter Related substances.
The marketing authorisation holder Pliva Croatia d.o.o., has on the caution assumption initiated a recall of this match from wholesalers and hospital pharmacies.
There are sufficient quantities of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion batches not affected by this quality defect and recall and that are available on the Croatian market.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.