The firm believes that the individuals using the Vitrakvi could consume the fungus and develop invasive blood fungal infections or potentially fatal pneumonia as they already have weakened immune systems
Bayer has recalled one lot of Vitrakvi drug. (Credit: Bayer AG)
Bayer has issued a voluntary recall of its cancer drug Vitrakvi (larotrectinib) in the US to the consumer/user level due to the presence of microbial contamination found during routine ongoing stability testing.
Vitrakvi is authorised for use in patients who have advanced solid tumour cancers that are NTRK gene fusion-positive.
The German pharmaceutical company is recalling Vitrakvi oral solution 20 mg/ml in 100ml glass bottles.
Bayer has observed Penicillium brevicompactum, a class of fungus that grows slowly, as the source of the contamination.
The firm believes that the individuals using the drug could consume the fungus and develop invasive blood fungal infections or potentially fatal pneumonia as they already have weakened immune systems.
As of now, the pharmaceutical company has not received any adverse events related to this recall.
A representative for the firm stated that 192 glass 100 ml bottles containing the drug’s oral solution version were part of the recalled lot.
The affected Vitrakvi lot has Lot# 2114228, an expiration date of February 29, 2024, and is packaged in a 100 mL glass bottle with NDC# 50419-392-01.
Between 3 January 2023, and 13 February 2023, lot # 2114228 was supplied to specialty pharmacies and wholesale distributors around the country.
On 8 November 2023, Bayer sent out a notice of this recall to all distributors and pharmacies. Qualanex has been hired by the company to oversee the product recall at the consumer level.
Vitrakvi distributors have received a recall notification letter from Qualanex, and the company will decide for distributors, speciality pharmacies, and customers to return the recalled lot.
Bayer said that customers who have recalled Vitrakvi products should stop the use of this lot immediately.
They can contact their physician or healthcare provider if they experience any problems related to the affected lot.
The German firm has informed the US Food and Drug Administration (FDA) about the recall.