Information on the recall of two batches of Tyrez 2.5 mg film-coated tablets (bisoprolol)
28.02.2014
The company Alkaloid d.o.o., marketing authorisation holder for Tyrez 2.5 mg film-coated tablets (bisoprolol), has informed the Agency for Medicinal Products and Medical Devices (HALMED) on the decision of the manufacturer, Alkaloid Int. d.o.o. on the recall of two batches of this medicinal product. Due to a quality defect discovered during further stability testing, the batches No 587770213 and 646340713 are being recalled from the market. The toxicological evaluation has confirmed no toxicological risk for patients. The medicinal product has been recalled due to preventive reasons at the level of wholesales, who are informed by the marketing authorisation holder about the recall.
There are other batches of Tyre2, 2.5 mg film-coated tablets currently available in Croatia and not affected by this quality defect and recall.
