Kyowa Kirin Limited
Mitomycin-C Kyowa, 2 mg, powder for solution for injection PL 16508/0042
Mitomycin-C Kyowa, 10 mg, powder for solution for injection PL 16508/0043
Mitomycin-C Kyowa, 20 mg, powder for solution for injection PL 16508/0044
Mitomycin-C Kyowa 40 mg, powder for intravesical solution PL 16508/0045
Brief description of the problem
Kyowa Kirin Ltd is recalling all unexpired batches of the products as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients.
Advice for healthcare professionals
Please immediately quarantine any units of these products which you have in your possession. Please return affected stock to your supplier using your suppliers approved process
Please see the Department of Health and Social Care and NHS England & Improvement, Supply Disruption Alert (SDA/2019/006)for further advice, including the use of unlicensed imports of mitomycin powder for solution for injection and intravesical solution
Advice for Wholesalers
If you have supplied these products to any other wholesaler, please notify these wholesalers with a copy of this recall notice, requesting that they quarantine and return any unsold quantities of these products to you.
Stuart Hay, Commercial Director
Iain Crolla, Commercial Manager
Hazel Kennett (Responsible Person) on telephone number
Martin Smith (Responsible Person)
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
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Published 7 November 2019