Reported May 8, 2019 · Terminated
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use…
US Worldmeds LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Worldmeds LLC · 4441 Springdale Rd · Louisville, KY · 40241-1086
Is this the product you have?
- Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist
- byUS WorldMeds, LLC, Louisville, KY 40241
- NDC27505-003-67
- Lot codes and dates
- Lot
17REV01Exp. 12/2019
- Lot
- Amount recalled
- 6456 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
This product could cause temporary or reversible health problems — stop using it.
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