AuroMedics Pharma LLC has recalled approximately 197,360 vials of Amiodarone Hydrochloride Injection, USP, a prescription medication used to treat life-threatening heart rhythm disorders. The recall was initiated because the liquid medication may contain visible crystallization or particulate matter. Consumers or healthcare providers should check their inventory for affected vials of the 150 mg, 450 mg, and 900 mg doses.
The presence of solid particles or crystals in an injectable medication can cause serious health issues, including inflammation, irritation of the blood vessels, or the formation of granulomas. If a particle blocks a blood vessel, it could lead to more severe complications in vital organs.
Healthcare provider consultation and pharmacy refund.
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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