News

Recall Active for Revonto

05/09/2019

US WorldMeds is recalling 6456 vials of Revonto (dantrolene sodium for injection), 20 mg/vial (NDC 27505-003-67), because the appearance of the reconstituted solution was out of specification during 24-month stability testing, according to the May 8, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects vials from lot 17REV01 (Exp. 12/19), which were distributed throughout the United States.

US WorldMeds voluntarily issued the recall April 25, 2019. At press time, the FDA had not yet issued a recall classification.

Revonto is an intravenous medication used to treat patients with malignant hyperthermia, a rare but potentially deadly hypermetabolic crisis that can occur with general anesthesia.

—Jolynn Tumolo

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