Class 4 Drug Caution in use - MITOCIN (MITOMYCIN) 20MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use 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

MHRA drug alert link: https://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?utm_medium=email&utm_campaign=govuk-notifications&utm_source=23f29568-2411-48f9-bc43-7b69aed25c18&utm_content=immediately                  

This is a caution in use only we are not accepting stock returns.

Further Information

For medical information queries, please contact:

Lucy Owen,

ProductLifeGroup

Tel: +44 (0) 1223 402660

Email: lowen@productlife-group.com

For more information or stock control queries, please contact:

Hussain Tahan

Vygoris Ltd

Tel: 020 3865 1682

Email: qualitylimited@vygoris.com

If you have any questions, then please contact your local Service Centre Customer Services team