Bayer recalls one lot of cancer drug Vitrakvi due to contamination
Send a link to a friend
[November 18, 2023]
(Reuters) -Bayer said on Friday it was voluntarily recalling one
lot of its cancer drug Vitrakvi in the U.S. 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.
[to top of second column]
|
![](../images/111823PIX/health23.jpg)
Logo of Bayer AG is pictured at the annual results news conference
of the German drugmaker in Leverkusen, Germany February 27, 2019.
REUTERS/Wolfgang Rattay/File Photo
![](http://archives.lincolndailynews.com/2023/Nov/18/images/ads/current/castlemanor_sda_FINANCIAL_2017.png) 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.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Devika Syamnath
and Rosalba O'Brien)
[© 2023 Thomson Reuters. All rights
reserved.]This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
![](http://archives.lincolndailynews.com/2023/Nov/18/images/ads/current/graue_sda_042021.png) |