The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for all unexpired batches of Mitomycin-C Kyowa 2 mg, 10 mg, 20 mg powder for solution for injection and 40 mg powder for intravesical solution.

Kyowa Kirin is recalling the products from pharmacies as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients.

Pharmacists are directed to quarantine the affected stocks immediately and return it to suppliers using their approved process.

Product details:

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

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