Notice on recall of one batch of Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etoposide) due to an error in the product name in the package leaflet and labelling
26.06.2014
Pfizer Croatia d.o.o., the marketing authorisation holder for Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etopodide), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of the batch HW52C of this medicine. The recall is due to an error in the product name in the package leaflet and labelling.
Naimly, after the renewal of the medicinal product, the product name was changed from Etoposide injection 100 mg to Etoposide Pfizer 20 mg/ml concentrate for solution for infusion. The symbol "ml” for the strength was omitted by mistake. Taking account that a medication error in terms of overdose may occur, this batch is being recalled on a caution assumption.
There are batches on the Croatian market labelled according to the previously valid marketing authorisation with the previous product name Etoposide injections 100 mg. As soon as the conditions have been fulfilled, Pfizer will place the product on the market according to the new marketing authorisation, including the correct name: Etoposide Pfizer 20 mg/concentrate for solution for infusion.
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.
