Class 4 Medicines Defect Information: Vygoris Limited, Mitocin (mitomycin) 20mg powder for solution for injection/infusion or intravesical use, EL (21)A/27

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.

113-12/20

Vygoris Limited

Active Pharmaceutical Ingredients: mitomycin

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.

This product is not being recalled and Vygoris Limited have confirmed that all packs currently in stock (at wholesalers) will be distributed onwards with a filter, and this stock, with filters will be available w/c 08 November 2021. Additionally, filters will be available with all new batches manufactured. If the pack arrives without a filter, please contact Vygoris Limited or Mawdsleys as detailed below.

Check the existing stock within your possession and identify if any of the Mitocin 20mg powder for solution for injection/infusion or intravesical batches listed above are impacted by this issue. Please note that in addition to your pharmacy, this includes clinics, wards and any other relevant locations.

Ensure that prior to treatment and where possible, filters are used. The filter remains available for dispatch from Vygoris Limited. Please contact Mawdsleys if you require filters directly.

MPW – Quest 90

Quest Park, Wheatley Hall Road

Doncaster

DN2 4LT

Email: [email protected]

Tel: +44 (0) 161 741 3365

For medical information queries, please contact:

Lucy Owen,

ProductLifeGroup

Tel: +44 (0) 1223 402660

Email: [email protected]

For more information or stock control queries, please contact:

Hussain Tahan

Vygoris Ltd

Tel: 020 3865 1682

Email: [email protected]

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice.

EL (21)A 27

Please also see the Direct Healthcare Professional Letter below for further guidance:

Vygoris DHPC