Bayer recalls VITRAKVI oral solution (20mg/mL, 100mL) due to Penicillium brevicompactum contamination found in stability testing. This medication is prescription-only and requires immediate action.
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Bayer is recalling VITRAKVI oral solution (20mg/mL, 100mL bottle) because routine testing found Penicillium brevicompactum mold. This medication is prescription-only and must be stopped if it's the recalled batch.
Penicillium brevicompactum mold was detected during routine stability testing. This mold can cause infections in immunocompromised patients who use the medication. The contamination occurred in the manufacturing process.
Prescription patients using VITRAKVI oral solution (20mg/mL, 100mL bottle) manufactured by Bayer HealthCare. Patients with specific cancer treatments are most at risk.
Check for the product name 'VITRAKVI', strength '20mg/mL', and size '100 mL bottle'. The NDC code is 50419-392-01 and lot number 2114228 (expires 02/29/2024).
Verify the product name, strength, and size to confirm if it matches the recalled VITRAKVI oral solution (20mg/mL, 100mL bottle).
The recall record states that Penicillium brevicompactum mold was found during routine testing, but does not specify if the product is safe to use after the recall. The remedy is null, so no specific action is required per the official notice.
Check for the product name 'VITRAKVI', strength '20mg/mL', and size '100 mL bottle'. The NDC code is 50419-392-01 and lot number 2114228 (expires 02/29/2024).
The recall record states that the remedy is null, meaning no specific action is required per the official notice. However, patients should contact their healthcare provider for guidance.
We’ve drafted a message you can send Bayer to request your refund or repair — edit it as you like.
Subject: Recall D-0145-2024 — Bayer Bayer Hello, I own a Bayer that is covered by recall D-0145-2024 from Bayer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
