PegIntron
Recall
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Medicines
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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 recall | 2 |
| BASG reference number | 640.224/2010 |
Further inquiry note
Page last modified:
12/07/2022