US Worldmeds LLC is recalling 6,456 vials of Revonto (dantrolene sodium for injection), 20 mg/vial, used for the treatment of malignant hyperthermia. The recall was initiated because stability testing at the 24-month mark revealed the presence of a precipitate (solid particles) in the liquid once the medication was prepared for injection. Consumers and healthcare providers should be aware that the presence of these particles means the product is out of specification and potentially unsafe for intravenous use. If you have this medication, you should contact your healthcare provider or pharmacist immediately for guidance.
Injecting a solution containing solid particles (precipitate) can lead to serious health complications, such as inflammation of the veins, blood clots, or blockages in small blood vessels, which could cause organ damage or other life-threatening events.
Contact healthcare provider and return product.
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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