Recall | Medicines | 29/11/2010

The marketing authorization holder informed its supplied customers by letters dated October 29 and November 25, 2010, that the sterility of the products cannot be guaranteed for the batches listed above.

Name of the medicinal product PegIntron Pulver und Lösungsmittel zur Herstellung einer Injektionslösung im vorgefüllten Injektor (Peginterferon alfa-2b)
50 mcg/0,5 ml, 80 mcg/0,5 ml, 100 mcg/0,5 ml, 120 mcg/0,5 ml, 150 mcg/0,5 ml
Marketing authorisation number(s) EU/1/00/131/032, EU/1/00/131/035-036, EU/1/00/131/039-040, EU/1/00/131/043-044, EU/1/00/131/048
Marketing authorisation holder Schering-Plough Europe
Batch number(s) 50 mcg: 8IRA60112, 8IRA60235, 8IRA60335, 9IRA60112

80 mcg: 8IRG60239, 7IRG60732, 8IRG60204, 8IRG60427, 8IRG60513, 8IRG60618, 8IRG60704, 8IRG61111, 9IRG60228

100 mcg: 8IRB60227, 8IRB60216, 8IRB60426, 8IRB60601, 8IRB60701, 9IRB60216, 9IRB60420

120 mcg: 8IRJ60629, 7IRJ61008, 8IRJ60130, 8IRJ60428, 8IRJ60622, 8IRJ60710, 8IRJ60908, 8IRJ60922, 9IRJ60603, 9IRJ60829

150 mcg: 8IRC60327, 8IRC60509, 8IRC60540, 8IRC60614, 8IRC60804, 9IRC60214, 9IRC60423, 9IRC60435
Classification of the recall2
BASG reference number 640.224/2010

Further inquiry note