Vistabel 4 Allergan - Einheiten/0,1 ml - Pulver zur Herstellung einer Injektionslösung

Recall | Medicines | 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
Email

Further inquiry note