Class 3 drug alert – Action within five days: Mitomycin-C Kyowa 10mg injection

A Class 3 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a certain batch of Mitomycin-C Kyowa 10mg Powder for Solution for Injection

DRUG ALERT

Class 3 drug alert – Action within five days

Ref: CLDA (18)A/09

Date 13 November 2018

Product name Mitomycin-C Kyowa 10mg powder for solution for injection
(Manufactured by Kyowa Kirin Ltd )

PL 16508/0043

A Class 3 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a certain batch of Mitomycin-C Kyowa 10mg Powder for Solution for Injection as stated in the table below:

The above batch has been recalled due to sub visible particles recorded at the 39 month time point; this is an out of specification result.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy team November 2018.