Sterilization problems, 31 batches of Mitomycin anticancer have been recalled
The Italian Medicines Agency has ordered the voluntary withdrawal, as a precaution, of some lots of the medicinal specialty mitomycin , an antitumor of the class of antibiotics, produced by the company Kyowa Kirin Srl. The provision was made necessary following the communication of the company concerning the deficiency of aseptic conditions during the production of the active ingredient present in the aforementioned drug.
Specifically, it deals with MITOMYCIN C * INIET 1FL 10MG – AIC016766026: the lots involved are the following:
- 6059788scad. 31/10/2019
- 6066251scad. 28/02/2020
- 6066252 due 29/02/2020
- 6069591 due 31/05/2020
- 6069832 due 31/05/2020
- 6071865 due 30/11/2020
- 6073096 due 28/02/2021
- 6075909 due 30/09/2021
- 6077579 due 30/09/2021
- 6081709 due 31/05/2022
- 6083274 due 31/05/2022
- 6084537scad. 31/10/2022
- 6087223 due 31/10/2022
- 6087460 due 31/10/2023
MITOMYCIN C * INIET 1FL 40MG - AIC 016766040 in lots:
- 6077034 due 31/10/2019
- 6077346scad.31 / 10/2019
- 6078416scad.31 / 10/2019
- 6078417 due 31/10/2019
- 6080423 due 31/05/2020
- 6081563 due 31/05/2020
- 6081564 due 31/05/2020
- 6082102 due 31/07/2020
- 6082103 due 31/07/2020
- 6082714 due 31/07/2020
- 6082716 due 31/07/2020
- 6083275 due 31/07/2020
- 6083276 due 31/08/2020
- 6084201 due 31/10/2020
- 6084425scad. 30/11/2020
- 6084673scad. 30/11/2020
- 6086858scad. 31/12/2020
- 6087459 due 28/02/2021
- 6087467 due 31/03/2021
Mitomycin is recommended for the treatment of certain types of neoplasms either alone or in association with other drugs or after the therapeutic protocol of election has failed. It has been used successfully in an attempt to improve the subjective and objective symptomatology of a large number of malignancies, including gastric, pancreatic, uterine and breast cancers; pulmonary adenocarcinoma; peritoneal carcinosis; colon, bladder, rectum and skin cancers. Furthermore, it has been used with some success in sarcomas, hepatocellular carcinomas, acute and chronic leukemias and Hodgkin's disease.