Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection／infusion or intravesical use |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use (batch number: 0-20071AB, 0-20081AB, 0-20102AB, 0-20112AA, 0-20042AA, 0-20013AD) may contain subvisible particles above the current specifications after reconstitution (>10µm: NMT 6000/vial), initially identified during stability studies. Vygoris Limited has confirmed that a single-use filtration device called the Millex® HV (0.45 μm/PVDF) - Syringe Filter will be included in each delivery of the product. This product is not being recalled.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-vygoris-limited-mitocin-mitomycin-20mg-powder-for-solution-for-injection-slash-infusion-or-intravesical-use-el-21-a-slash-27
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Nov 9, 2021
Issued at HKT 14:00
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