Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of Vitrakvi (larotrectinib) oral solution, 20 mg/mL, in 100 mL bottles. This recall was initiated after routine stability testing identified microbial contamination from a fungus known as Penicillium brevicompactum. Vitrakvi is a prescription medication used to treat certain types of cancer. No incidents or injuries have been reported to date in connection with this issue.
The presence of microbial contamination in this medication poses a serious risk of infection, particularly for cancer patients with weakened immune systems who are the intended users of this drug.
You have 2 options:
Quantity: 192 bottles. Active ingredient: larotrectinib (equivalent to 24.6 mg/mL larotrectinib sulfate).
Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, Lot# 2114228 and an expiration date of February 29, 2024
Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, Lot# 2114228 and an expiration date of February 29, 2024
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.