Accord Healthcare, Inc. is recalling 11,214 vials of Cisplatin Injection, 100mg/100mL (1mg/mL). The recall was initiated because the medication failed to meet quality specifications for impurities and degradation, meaning the drug may contain substances outside of approved limits or the active ingredient is breaking down too quickly. No injuries or incidents have been reported to date. This medication is typically administered by healthcare professionals in clinical settings; patients should discuss any concerns with their treatment team.
The presence of impurities or degradation products beyond specified limits can potentially impact the safety or effectiveness of the chemotherapy treatment. While no specific adverse events have been reported, using a product that does not meet these quality standards poses a moderate risk to patients.
Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India for Accord Healthcare Inc.
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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