US Worldmeds Recalls Revonto Dantrolene Sodium Injection Due to Precipitate
US Worldmeds LLC is recalling 6,456 vials of Revonto (dantrolene sodium for injection) because the reconstituted solution showed out-of-specification precipitate during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific injuries or hospitalizations are reported in the source text, and the hazard is a quality defect (precipitate) rather than a high-risk pathogen or structural failure.
Plain-English summary
US Worldmeds LLC is voluntarily recalling 6,456 vials of Revonto (dantrolene sodium for injection), 20 mg/vial. The product is a prescription medication intended for the intravenous treatment of malignant hyperthermia. The recall involves Lot 17REV01, which has an expiration date of 12/2019. The product was distributed nationwide in the United States.
The recall was initiated because the appearance of the reconstituted solution was found to be out of specification during a 24-month stability time point analysis. Specifically, the presence of precipitate was identified in the solution. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should discontinue use of the affected vials. US Worldmeds LLC is the recalling firm. The product is manufactured in Italy and distributed by US Worldmeds LLC in Louisville, KY.
The recalled product
- Product
- Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
- Manufacturer
- US Worldmeds LLC
- Category
- Drug — Injectable Medication
- Affected units
- 6,456
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 17REV01
- Exp. 12/2019
Distribution
Distributed nationwide across the United States.
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