THE Food and Drug Administration (FDA) has ordered the recall of four batches of a chemotherapy drug after they were found to be contaminated.
Recalled were batches I23F025A, I23J001A, I23K002A, I23H018A) of “Methotrexate 100 mg/mL solution for injection (IM/IV) [Trexasaph].”
“The Trexasaph, with Batch No. I23J001A, failed the sterility test and was found positive with pseudomonas aeruginosa, indicating contamination of the products,” said the FDA.
It said pseudomonas aeruginosa bloodstream infection is a serious infection that may lead to death.
“Any product that has any contamination and is administered directly in the body would present serious risks to patients,” it said.
The FDA said methotrexate is a chemotherapy agent and immune system suppressant used for treatment of neoplastic disease, such as trophoblastic neoplasms and leukemia, and the symptomatic treatment of recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy.
“Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections,” said FDA.
The FDA urged those suspecting to have adverse reaction from the use of the products, to report to the agency via the link: https://bit.ly/FDAPHReportSideEffect.
