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

Recalls and Alerts

Class 4 Caution in Use

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                  

Pip code

Product description

Supplier

Batch numbers

ALLIANCE DO NOT STOCK

MITOCIN (MITOMYCIN) 20MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

VYGORIS LIMITED

0-20071AB

0-20081AB

0-20102AB

0-20112AA

0-20042AA

0-20013AD

 

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