On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.

FDA update

Larotrectinib is indicated for the treatment of solid tumors that are NTRK gene–fusion positive, and patients receiving the agent may be immunocompromised. Bayer said that although data on Penicillium brevicompactum–related human pathology are sparse, scientists have documented cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Bayer concluded that patients on larotrectinib with underlying immunosuppression who ingest Penicillium brevicompactum have a reasonable probability of developing life-threatening invasive fungal blood infections or pneumonia. To date, the company has not received any reports of related adverse events.

The affected lot is packaged in a 100 ml glass bottle labeled with NDC 50419-392-01, Lot 2114228, and a February 29, 2024, expiration date. The lot was shipped to wholesale distributors and specialty pharmacies nationwide from January 3–February 13, 2023. View images of the product bottle and carton label.

Bayer notified all distributors and pharmacies about the recall on November 8, 2023, and engaged Qualanex to manage the recall to the consumer level. Qualanex sent distributors a recall notification letter is arranging for distributors, specialty pharmacies, and consumers to return the recalled lot.

Consumers who have the recalled product should immediately stop using it and contact their healthcare provider if they have any questions, concerns, or related problems. For general questions regarding the recall, consumers can email Qualanex or call 888-280-2043 Monday–Friday from 7 am–4 pm CT.

Clinicians or prescribers who have questions regarding the recall can contact the Bayer Medical Information Call Center at 888-842-2937 Monday–Friday from 8:30 am–8 pm ET. Healthcare providers should report any adverse reactions or quality problems experienced with the use of any product or device to FDA’s MedWatch Adverse Event Reporting program.