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

Recall Number: D-1275-2019

Firm: US Worldmeds LLC

Classification: Class II

Status: Terminated

Report Date: 20190508

Initiation Date: 20190425

Termination Date: 20220917

Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.

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