MabThera (Inopha)
Recall
|
Medicines
|
03/09/2014
The parallel distributor informed its supplied customers on 03.09.2014 that a counterfeit had occurred in the batch originating from Romania, which was identified by optical deviations on the stopper and the missing flip-off cap of a piercing bottle.
| Name of the medicinal product | MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/98/067/002 |
| Marketing authorisation holder | Roche Registration Limited Paralleldistribution: INOPHA GmbH |
| Batch number(s) | H0656B03 |
| Classification of the recall | 1 |
| BASG reference number | INS - 640.001 - 1 212 |
Further inquiry note
Page last modified:
12/07/2022