The Chief Pharmaceutical Inspector announced the withdrawal of two batches of Misintu from the market throughout the country. The reason for the decision is the reporting of a quality defect in the form of contamination, the nature and origin of which are unknown.
The Chief Pharmaceutical Inspector (GIF) announced on Monday that he had decided to withdraw from circulation throughout the country the medicinal product Misintu (Mitomycinum), solution for injection and infusion, 20 mg x 1 vial, in two series:
– series number 30313010, expiration date: March 6, 2025, – series number 30845510, expiration date: August 11, 2025.
The responsible entity is Koçsel İlaç San. ve Tic. A.Ş. with headquarters in Turkey. In turn, the entity that obtained consent for temporary marketing admission of the above-mentioned medicinal product is Genesis Pharm sp. z o. o limited partnership, ul. Obywatelska 128/152, 94-104 Łódź.
At the same time, GIF announced that it had also decided to ban the marketing of the indicated product series.
These decisions are immediately enforceable.
Reason for drug withdrawal
The Chief Pharmaceutical Inspector received information from the Małopolska Provincial Pharmaceutical Inspector about a suspicion of a quality defect in the medicinal product Misintu, (Mitomycinum), solution for injection and infusion, 20 mg x 1 vial with batch number 30313010 and expiry date of March 6, reported by a hospital pharmacy in Krakow. 2025.
The reported quality defect was that “in the solutions prepared by professional medical staff, after dissolving the drug in water for injection, there were insoluble particles of unknown nature and origin visible to the naked eye.”
“In the course of the explanatory proceedings, including those conducted with the participation of the Małopolska Provincial Pharmaceutical Inspector and the Silesian Provincial Pharmaceutical Inspector, it was confirmed that the inconsistency described above concerns two batches of the Misintu medicinal product, i.e.: batch number 30313010 and batch number 30845510, and occurs during the preparation of the medicine by the staff specialist in specialist hospitals in two voivodeships,” we read in the justification of the decision.
Misintu is used to treat bladder cancer, breast cancer, head and neck cancer, stomach and pancreatic cancer, prostate cancer and cervical cancer.
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