Vistabel 4 Allergan - Einheiten/0,1 ml - Pulver zur Herstellung einer Injektionslösung
Recall
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Medicines
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27/05/2021
The marketing authorisation holder has informed its customers on May 25, 2021 that batch number C6904C3 "Vistabel 4 Allergan - Einheiten/0,1 ml - Pulver zur Herstellung einer Injektionslösung" is being recalled because there is a risk of incorrect dilution and administration of double dose.
The information on the outer carton refers to a 50-unit vial. Also, the dilution volume is given for a 50-unit vial (1.25ml) instead of the correct dilution (2.5ml) for a 100-unit vial. All the information in the leaflet and on the vial is correct.
| Name of the medicinal product | Vistabel 4 Allergan - Einheiten/0,1 ml - Pulver zur Herstellung einer Injektionslösung |
|---|---|
| Marketing authorisation number(s) | 1-26323 |
| CIP code | 4955813 |
| Marketing authorisation holder | Allergan Pharmaceuticals Ireland |
| Batch number(s) | C6904C3 |
| Expiry date | 02/29/2024 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-3544 |
Further inquiry note
Page last modified:
27/05/2021