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7 November 2019 by Jacquie Lee

Class 2 Medicines Recall: Kyowa Kirin Limited Mitomycin-C Kyowa, All Strengths (see alert for more information), (EL (19)A/33)

  • Wales
  • England
  • Scotland
  • Northern Ireland

This recall affects Mitomycin-C Kyowa 2 mg (PL 16508/0042), 10 mg (PL 16508/0043), 20 mg (PL 16508/0044), powder for solution for injection, and Mitomycin-C Kyowa 40 mg (PL 16508/0045), powder for intravesical solution.

MDR Number

MDR 121-09/19

Company name

Kyowa Kirin Limited

Product description

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 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 to 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

Company contacts for further information

For Stock enquiries please contact:

Stuart Hay, Commercial Director

  • Telephone: +44 (0) 1896 664045
  • Mobile: +44 (0) 7968 983286

Iain Crolla, Commercial Manager

  • Telephone: +44 (0) 1896 661661
  • Mobile: +44 (0) 777 6748868

For Medical Information enquiries please contact:

For Quality information please contact:

Hazel Kennett (Responsible Person) on telephone number

  • Telephone: +44 (0) 1896 664025
  • Mobile: +44 (0) 7989 991831

Martin Smith (Responsible Person)

  • Telephone: +44 (0)1896 664030
  • Mobile: +44 (0)7904 671 807

To access the full recall:

https://assets.publishing.service.gov.uk/media/5dc3e45740f0b6379a7acc80/EL_19_A_33_Final.pdf

Drug alert class 2

Drug alert class 2

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