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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 07-Nov-2019 12:59:50

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • DHSC Supply Disruption - Medicines

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, KYOWA KIRIN LIMITED, MITOMYCIN-C KYOWA 2MG, 10MG, 20MG, POWDER FOR SOLUTION FOR INJECTION; MITOMYCIN-C KYOWA 40MG, POWDER FOR INTRAVESICAL SOLUTION

Broadcast content: Kyowa Kirin Ltd is recalling all unexpired batches of the above product as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients. 

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.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Alert reference: EL (19)A/33

Attachments:
Cascade to:
  • #HospitalPharmacy#


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency