FDA-Drug2019-05-08Class II
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
US Worldmeds LLC
Hazard
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Sold states
Nationwide in the USA
Affected count
6456 vials
Manufactured in
4441 Springdale Rd, N/A, Louisville, KY, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1275-2019Don't want to check this manually?
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