Product Safety Recalls

Product Recall Tracker

DANTROLENE SODIUM Recall D-1080-2022

Description: Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67

DANTROLENE SODIUM Recall D-1080-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1080-2022
Event ID89646
BrandREVONTO
Generic NameDANTROLENE SODIUM
ManufacturerDANTROLENE SODIUM
Original Package?1
Active SubstanceDANTROLENE SODIUM
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity16 cartons/6 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC27505-003
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier287M0347EV
Drug Application NumberANDA078378
Structured Product Labeling (SPL ID)cfcfad0f-e5e4-bfd6-e053-2995a90a0cef
Structured Product Labeling (SPL Set ID)78801254-73a0-44ca-9222-7b3581af82d8
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