WASHINGTON (Reuters): Bayer said on Friday it was voluntarily recalling one lot of its cancer drug Vitrakvi in the US due to the presence of microbial contamination that was observed during routine stability testing.
The company has not received any adverse event reports related to the lot to date, it said.
The drug, Vitrakvi, is approved for use in patients who have advanced solid tumor cancers with a rare gene mutation.
Bayer identified Penicillium brevicompactum, a type of slow-growing fungus, as the source of the contamination.
It said there was a “reasonable probability” that ingestion of the fungus in patients using the drug may result in invasive fungal infections of the blood or life-threatening pneumonia since they are already immunocompromised.
A company spokesperson said the recalled lot comprised of 192 100ml glass bottles of the oral solution form of the drug.
“No disruption to patients for accessing Vitrakvi,” Bayer said.
Bayer said the recalled lot was distributed to wholesalers and specialty pharmacies in the U.S. between Jan. 3 and Feb. 13 this year and it informed them of the recall on Nov. 8. The impacted lot carries an expiration date of Feb. 29, 2024.
Customers who have the recalled lot should immediately stop use of the drug and contact their physician or healthcare provider, the company said.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
