US Worldmeds LLC recalls Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only
Recalled May 8, 2019 · FDA recall D-1275-2019 · US Worldmeds
Hazard
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis. · FDA Class II
Units
6456 vials
Sold at
Nationwide in the USA
Description
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
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(s)
US Worldmeds LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →