FDAApril 25, 2019drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
What to do
FDA enforcement status: Terminated
Brands named
us worldmeds
Recall history
No related federal recalls on record for this brand yet.
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