Voluntary recall of Mitomycin-C Kyowa Injection

The Health Sciences Authority (HSA) would like to inform healthcare professionals on the retail level recall of Mitomycin-C Kyowa products, Mitomycin-C Kyowa for Injection 2mg/vial and Mitomycin-C Kyowa for Injection 10mg/vial, by Kyowa Kirin. The recall is conducted as a precautionary measure due to concerns that the products’ sterility cannot be guaranteed due to manufacturing deviations. The overall risk of microbial contamination is assessed to be low. Healthcare professionals are advised not to initiate new patients on the affected injections and switch existing patients on them to alternative therapies. In specific situations where patients cannot be prescribed with alternative therapies, healthcare professionals are advised to review the benefit-risk of continuing treatment with the affected injections and consider discussing the potential risks of using the affected injections with the patients. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.