Bayer is voluntarily recalling one lot of cancer med Vitrakvi following the discovery of microbial contamination during routine ongoing stability testing.
The recalled lot is comprised of 192 100ml glass bottles of the oral solution, distributed to wholesale distributors and specialty pharmacies between January 3, 2023 and February 13, 2023.
Bayer identified Penicillium brevicompactum, a type of slow-growing fungus, as the source of the contamination. According to Bayer, because Vitrakvi patients may be immunocompromised there is a "reasonable probability" that ingestion of Penicillium brevicompactum may result in invasive fungal infections of the blood or pneumonia that can be life-threatening.
Vitrakvi was first approved by the FDA in 2018 for the treatment of patients with solid tumors that have a specific genetic biomarker, a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
Regarding the recall, Bayer says it has not received reports of any adverse events.