ACTOSOLV, Pulver zur Herstellung einer Injektions-/Infusionslösung

Recall | Medicines | 14/12/2021

AGEA Pharma GmbH informed its customers on December 13, 2021 that particles have been detected in the mentioned batches. Therefore, the marketing authorisation holder is recalling these batches as a precautionary measure.

The medicinal products are authorised in Belgium and placed on the market in Austria under the Austrian Act on the Import of Medicinal Products.

Name of the medicinal product 1) ACTOSOLV 100 000 IE, Pulver zur Herstellung einer Injektions-/Infusionslösung
2) ACTOSOLV 600 000 IE, Pulver zur Herstellung einer Injektions-/Infusionslösung
Marketing authorisation number(s) 1) BE140777
2) BE156834
Marketing authorisation holder EUMEDICA Pharmaceuticals GmbH
Distributor AGEA Pharma GmbH
Batch number(s) 1)
Batch, Expiry Date
P02458, 31/05/2022
2)
Batch, Expiry Date
P02412, 31/05/2022
P02712, 31/12/2022
Classification of the recall1
Depth of recall Pharmacies
BASG reference number INS-640.001-3717
Email

Further inquiry note