Bayer Recalls One Lot of Vitrakvi Because of Contamination


Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

Contamination with Penicillium brevicompactum seen during routine ongoing stability testing has led Bayer to recall one lot of Vitrakvi (larotrectinib) oral solution.

Vitrakvi is indicated to treat patients with solid tumors that are NTRK gene fusion positive. Patients who are immunocompromised may be at risk for invasive fungal infections of the blood or pneumonia that can be life-threatening. In a statement, Bayer said there is little data on Penicillium brevicompactum, but there have been cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression.

To date, Bayer has not received any reports of adverse events.

The impacted lot of Vitrakvi is packaged in a 100mL glass bottle with NDC 50419-392-01. The lot number 2114228 with an expiration date of February 29, 2024. This lot was distributed to wholesale distributors and specialty pharmacies nationwide between Jan. 3, 2023, and Feb. 13, 2023.

Qualanex is managing the recall.

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