Recall of two lots of the medicinal product BiCNU injection 100 mg
23.12.2009
The Agency for Medicinal Products and Medical Devices has recalled two lots of the medicinal product BiCNU injection 100 mg, the package containing 1 vial of powder and 1 vial or ampoule of diluent, in a box, their numbers being 9F54881 and 9D47031, of the manufacturer Bristol-Myers Squibb, due to suspected quality defect of these two lots of the medicinal product.
The marketing authorisation holder for this product, the company PharmaSwiss d.o.o., on 23 December 2009, informed the Agency for Medicinal Products and Medical Devices of potential sterility concern in the above two lots of the medicinal product. The Agency informed all hospitals, whereas the marketing authorisation holder PharmaSwisss d.o.o. informed all wholesalers, about this suspected defect.
