Class 2 Medicines recall: Mitomycin-C Kyowa, 2 mg, 10mg, 20mg pdr for sol for inj & 40mg pdr for intravesical sol (Kyowa Kirin Ltd)

Class 2 Medicines recall: Mitomycin-C Kyowa, 2 mg, 10mg, 20mg pdr for sol for inj & 40mg pdr for intravesical sol (Kyowa Kirin Ltd)

November 7, 2019

Class 2 MHRA medicines recall – Mitomycin-C Kyowa, 2 mg, 10mg, 20mg pdr for sol for inj & 40mg pdr for intravesical sol (Kyowa Kirin Ltd)

Drug alert number: EL (19)A/33

Date issued: 7 November 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Mitomycin-C Kyowa, 2 mg, 10mg, 20mg pdr for sol for inj & 40mg pdr for intravesical sol (Kyowa Kirin Ltd)

Kyowa Kirin Ltd is recalling all unexpired batches of Mitomycin-C Kyowa powder for sol for inj listed below as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients.

Product Product License
Mitomycin-C Kyowa, 2 mg, powder for solution for injection. 16508/0042
Mitomycin-C Kyowa, 10 mg, powder for solution for injection. 16508/0043
Mitomycin-C Kyowa, 20 mg, powder for solution for injection. 16508/0044
Mitomycin-C Kyowa 40 mg, powder for intravesical solution 16508/0045

Advice for healthcare professionals

Quarantine any of the above listed products which you have in your possession and return to your supplier using your suppliers approved process.

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 drug alert can be viewed here.

For stock enquiries, please contact Stuart Hay, Commercial Director: 01896 664045 / 07968 983286 Stuart.Hay@kyowakirin.com
For medical Information enquiries: 01896 664 000 medinfo@kyowakirin.com

 



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