FDAApril 25, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

us worldmeds

Recall history

No related federal recalls on record for this brand yet.

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