Zydus Pharmaceuticals (USA) Inc. is recalling 38,871 vials of Nelarabine Injection (nelarabine), 250mg/50mL, (5mg/mL). This voluntary recall was initiated because the drug failed specifications for impurities and degradation during testing. These failures mean the medication may contain higher-than-allowed levels of unintended chemical compounds, which could affect the safety or effectiveness of the chemotherapy treatment.
Failed impurity and degradation specifications indicate that the active drug has broken down or contains unintended chemicals. In an injectable medication used for chemotherapy, these impurities can lead to unpredictable side effects or reduced treatment efficacy.
Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India. Quantity: 36,978 vials.
Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India. Quantity: 1,893 vials.
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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