PlainRecalls
FDA Drug Moderate Class II Terminated

Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1081-2022

Product Description

Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
49 cartons/6 vials each
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 49 cartons/6 vials each.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1081-2022.