Respreeza and Mononine
Recall
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Medicines
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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 |
Further inquiry note
Page last modified:
29/01/2021