FDA recall D-1275-2019

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-25

Report date

2019-05-08

Termination date

2022-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1275-2019