Mckesson Medical-Surgical recalls Revonto (dantrolene sodium for injection) due to temperature abuse risks. Products may have been shipped without proper temperature control, potentially causing safety issues.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling Revonto (dantrolene sodium for injection) 20 mg/vial, 6-count boxes because of temperature abuse risks. This could lead to unsafe conditions if the product is exposed to incorrect temperatures during storage or transport.
The product may have been exposed to temperatures outside the required range during storage or transport. This temperature abuse could compromise the drug's safety and effectiveness, potentially leading to adverse effects if used improperly.
Prescription patients who received Revonto from a pharmacy or healthcare provider. Healthcare professionals handling the product may be at risk if temperature control is inadequate.
Check for the product name 'Revonto', 20 mg/vial, 6-count box, and the NDC code 78670-003-67. The recall affects prescription products distributed by Mckesson Medical-Surgical.
Identify the product by checking the NDC code 78670-003-67 and the label for 'Revonto (dantrolene sodium for injection)'
The recall is due to temperature abuse risks where the product may have been exposed to incorrect temperatures during storage or transport.
Look for the product name 'Revonto', 20 mg/vial, 6-count box, and the NDC code 78670-003-67.
The recall does not specify a remedy, so contact your pharmacy or healthcare provider for guidance.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall D-1081-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1081-2022 from Mckesson Medical-Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
