Report of suspected quality defect of the medicinal product Talofen (promazine) 25 mg/ml, Lot No. 9814
07.05.2010
On 7 May 2010, the Agency for Medicinal Products and Medical Devices received a report on suspected quality defect of the medicinal product Talofen (promazine) 25 mg/ml, lot number 9814, manufactured by Pierrel S.p.A., Italy. Talofen is not authorised for marketing in the Republic of Croatia; it is only exceptionally imported for the treatment of patients in health institutions.
A quality defect is suspected because it has been observed that, after the contents of two ampoules was drawn into two separate syringes, the contents of one syringe was colourless and of the other yellow-brown.
The Agency for Medicinal Products and Medical Devices asked the importer, Medika d.d., to temporarily recall the above lot of the medicinal product and submit it to the Agency for quality control. After the control, the Agency will inform the public of the results thereof.
