ACTOSOLV, Pulver zur Herstellung einer Injektions-/Infusionslösung
Recall
|
Medicines
|
28/12/2021
AGEA Pharma GmbH informed its customers on December 27, 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 |
| Batch number(s) | 1) Batch, Expiry Date P02591, 09/2022 P02681, 11/2022 2) Batch, Expiry Date P02255, 03/2022 P02381, 05/2022 |
| Classification of the recall | 1 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3738 |
Further inquiry note
Page last modified:
28/12/2021