Recall of four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, of the manufacturer Baxter AG, Austria
15.04.2010
The Agency for Medicinal Products and Medical Devices recalled four lots of the medicinal product IMMUNINE 600 I.U. powder and solvent for solution for injection or infusion, the lots in question being VNC1J011-AA, VNC1J011-AB, VNC1J011-AC, and VNC1J011-AD, of the manufacturer Baxter AG, Austria, due to a suspected quality defect.
On 14 April 2010, the Agency received a notice from the World Health Organisation stating a suspicion that the quality of the solvent, water for injection, in the above lots of the medicinal product is inadequate, which in addition to the powder with the active substance makes an integral part of the medicinal product IMMUNINE 600 I.U.
The abovementioned medicinal product in the Republic of Croatia is distributed only to the hospital institutions which were informed by the Agency of this suspected defect. The marketing authorisation holder for the Republic of Croatia, Agmar d.o.o., informed the Agency that the above lots of the medicinal products would be replaced by others in accordance with the manufacturer's instructions.
