Medicinal Products

Recall of three batches of the medicinal product Oxaliplatin Pliva concentrate for solution for infusion (oxaliplatin)


Three batches of the medicinal product Oxaliplatin Pliva, concentrate for solution for infusion (oxaliplatin) with batch numbers 12G12LM, 11A24KF and 12I14LJ, manufactured by Pliva Hrvatska d.o.o., Zagreb, Republic of Croatia that are suspected to have a possible quality defect are withdrawn from the Croatian market.

The Agency for Medicinal Products and Medical Devices (HALMED) has received an adverse reaction report from health care professionals to batches 12G12LM Oxaliplatin Pliva 100 mg/20 ml concentrate for solution for infusion (shelf-life 07/2014) and 11A24KF Oxaliplatin Pliva 50 mg/10 ml concentrate for solution for infusion (shelf-life 01/2014). The suspected quality defect has been based on the reported adverse reactions, hence in order to test the quality of the batches in HALMED, on 21 February the Pharmaceutical Inspectorate of the Ministry of Health was asked to sample the product.

On 22 February 2013, HALMED received a notice about the suspected quality defect of the medicinal product by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). The suspicion arose after AIFA received adverse reaction reports from Italy, due to which AIFA requested a suspension of distribution until the quality control of the product has been proved.

HALMED has informed about the recall all health care facilities in Croatia that received the suspicious batches. The marketing authorisation holdershas been requested to inform about the recall all distributers and to request from them to stop the distribution and to withdraw the stocks of the above mentioned batches from hospital pharmacies.

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.