US Worldmeds LLC recalls Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Onl…

Recall date

April 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1275-2019

FDA classification

Class II

Brand / firm

US Worldmeds LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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