Respreeza and Mononine

Recall | Medicines | 29/01/2021

The marketing authorisation holder informed its customers on January 29, 2021 that a potential risk to the product quality was detected due to an improper aseptic procedure during the filling process.

For this reason, the affected batches are recalled as a precautionary measure.

Name of the medicinal product 1) Respreeza 1.000 mg Pulver und Lösungsmittel zur Herstellung einer Infusionslösung
2) Respreeza 4.000 mg Pulver und Lösungsmittel zur Herstellung einer Infusionslösung
3) Mononine 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung
Marketing authorisation number(s) 1) EU/1/15/1006/001
2) EU/1/15/1006/002
3) 2-00315
CIP code 1) 4227290
2) 4955977
3) 2478668
Marketing authorisation holder CSL Behring GmbH
Batch number(s) 1) Batch Numbers, Expiry Date
P100127169, 03.2022
P100043489, 08.2021
P100258951, 12.2022
P100266788, 04.2023
P100018411, 03.2021
P100061199, 08.2021
P100061530, 10.2021
P100072966, 11.2021

2) Batch Numbers, Expiry Date
P100264773, 09.2021

3) Batch Numbers, Expiry Date
P100157506, 04.2021
Classification of the recall 2
Depth of recall Pharmacies
BASG reference number INS-640.001-3405
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