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
Reason for recall: Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Recall initiated: 20190425
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated