Areva Pharmaceuticals is recalling 3,287 vials of Irinotecan Hydrochloride Injection, USP (40 mg/2 mL), a prescription chemotherapy drug. The recall was initiated because the manufacturer received a Warning Letter from the FDA regarding Current Good Manufacturing Practice (CGMP) deviations, including inadequate investigations into product quality and consumer complaints. While no specific patient injuries have been reported, these manufacturing failures mean the product may not meet safety and quality standards. Consumers should contact their doctor or pharmacist immediately if they have been treated with this medication.
The drug was produced in a facility that failed to properly investigate quality deviations and consumer complaints, which could result in a product that is ineffective or contains unknown impurities, potentially compromising patient treatment.
Healthcare provider consultation and refund
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 · Raw API Response
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