Bayer has announced a voluntary recall of a single lot of its cancer therapy Vitrakvi (larotrectinib) oral solution 20mg/mL, available in 100mL glass bottles.

The consumer-level recall comes after the company detected cases of microbial contamination with Penicillium brevicompactum during routine stability inspections.

Vitrakvi treats NTRK gene fusion-positive solid tumours. Patients receiving the drug may therefore already be immunocompromised. 

Penicillium brevicompactum has not been found to impact human pathology in the literature, but cases of invasive disease have been reported to be caused by such Penicillium species, especially in those with underlying immunosuppression. 

In a press statement, Bayer said: “Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. 

“To date, Bayer has not received any adverse events related to this recall.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company asked anyone who has the recalled product lot to cease its usage immediately and reach out to their physician or healthcare provider if they face any issues or have queries.

Bayer is issuing this product recall with the US Food and Drug Administration’s knowledge.

The company has informed all distributors and pharmacies of the latest update and has selected Qualanex to handle the product recall at the consumer level. 

Qualanex has notified distributors of Vitrakvi via a recall notification letter. The company will make arrangements for distributors, consumers and pharmacies to return the recalled product lot. 

Any adverse reactions or quality-related issues encountered following the usage of Vitrakvi can be notified to the MedWatch Adverse Event Reporting programme of the FDA either online, by mail or by fax.

This content was updated on 25 January 2024