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.
|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|