Drug product
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
D-1275-2019
Product summary
- Firm
- US Worldmeds LLC
- Event
- Event 82660
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6456 vials
- Official record key
drug-enforcement:D-1275-2019
Official wording
Reason: Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Code information: Lot: 17REV01, Exp. 12/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification