Mylan Institutional LLC is recalling approximately 15,089 cartons of Amiodarone Hydrochloride Injection, USP and Tranexamic Acid Injection, USP due to a labeling mix-up. Cartons labeled as Tranexamic Acid may actually contain vials of Amiodarone HCl, and cartons labeled as Amiodarone HCl may contain vials of Tranexamic Acid. These products were distributed nationwide in the United States and were manufactured for hospital or clinical use.
A labeling mix-up could lead to the administration of the wrong medication, which is particularly dangerous in emergency or critical care settings. Receiving the incorrect drug could result in a failure to treat the patient's actual condition or cause adverse effects from the unneeded medication.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.
Vial label, Amiodarone HCl Injection
Carton label, Amiodarone HCl Injection
Vial label, Tranexamic Acid Injection
Carton label, Tranexamic Acid Injection
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
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