D-1275-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 25, 2019
- Termination Date
- September 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6456 vials
Product Description
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
Reason for Recall
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17REV01, Exp. 12/2019