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

Medicines Healthcare Products Regulatory Agency

November 7
13:00 2019

Product information

PL number

PL 16508/0042

PL 16508/0043

PL 16508/0044

PL 16508/0045

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 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.

Company contacts for further information

For Stock enquiries please contact:

Stuart Hay, Commercial Director

Iain Crolla, Commercial Manager

For Medical Information enquiries please contact:

For Quality information please contact:

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.

Download the document

Class 2 Medicines Recall: Kyowa Kirin Limited Mitomycin-C Kyowa

Published 7 November 2019

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