BCG, mitomycin, mito-extra
Recall
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Medicines
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11/10/2018
The marketing authorization holder informed the supplied customers via its distribution partner in a letter dated 01.10.2018 that the urology catheters of the company ConvaTec may exhibit unsterility. In tests conducted with the packaging of the catheters, the possibility of breaking the sterile barrier was detected. Thus, the catheters of the company ConvaTec may no longer be used and must be removed accordingly. The drug specialties themselves and catheters of other manufacturers, which are alternatively packed, are not affected.
| Name of the medicinal product | 1. BCG-medac Pulver und Lösungsmittel zur Herstellung einer Suspension zur intra-vesikalen Anwendung 2. Mitomycin medac 20 mg Pulver und Lösungsmittel zur Herstellung einer Lösung zur intravesikalen Anwendung 3. mito-extra 40 mg Pulver und Lösungsmittel zur Herstellung einer Lösung zur intravesikalen Anwendung |
|---|---|
| Marketing authorisation number(s) | 1. 1-24620 2. 137118 3. Nicht anwendbar ( Inverkehrbringung gemäß Arzneiwareneinfuhrgesetz) |
| Marketing authorisation holder | Medac Gesellschaft für klinische Spezialpräparate mbH Durchführung Vertrieb und Rückruf: AGEA Pharma GmbH |
| Batch number(s) | Alle Chargen |
| Classification of the recall | 3 |
| BASG reference number | INS-640.001-2648 |
Further inquiry note
Page last modified:
12/07/2022