Carboplatin "Ebewe"

Recall | Medicines | 02/04/2012

The marketing authorization holder has informed its supplied customers by letter dated April 02, 2012, that an internal stability test after 15 months of storage has revealed the occurrence of visual particles. The recall affects all dose forms of Carboplatin 10 mg/ml vials (50mg/5ml, 150mg/15ml, 450mg/45ml and 1000mg/100ml).

Name of the medicinal product Carboplatin "Ebewe" 10 mg/ml - Konzentrat zur Infusionsbereitung
Marketing authorisation number(s) 1-22395
Marketing authorisation holder EBEWE Pharma Ges.m.b.H. Nfg.KG
Batch number(s) Alle Chargen innerhalb der Laufzeit
Classification of the recall2
BASG reference number INS-640.001-0409
Email

Further inquiry note