Prescription injection Revonto recalled due to manufacturing temperature deviation
Revonto (dantrolene sodium) injection is being recalled due to manufacturing deviations involving temperature abuse. Approximately 49 cartons were distributed nationwide; healthcare providers should contact their supplier for guidance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall of a precautionary nature due to manufacturing deviations (temperature abuse). No illnesses, injuries, or hospitalizations are reported. The hazard is potential drug stability or efficacy degradation from improper storage conditions.
Plain-English summary
Revonto (dantrolene sodium for injection), 20 mg/vial, is being recalled due to current good manufacturing practice (cGMP) deviations, specifically temperature abuse during the manufacturing process. The recall was initiated by McKesson Medical-Surgical Inc., the distributor, on behalf of the manufacturer US WorldMeds, Inc.
The recall involves approximately 49 cartons containing 6 vials each that were distributed to customers nationwide. The specific lot numbers affected vary by customer, and McKesson has communicated directly with affected consignees regarding the distribution dates and potential shipment dates relevant to each location.
Healthcare providers and pharmacies that received this product should consult the recall notification from McKesson for specific lot information and guidance. Patients currently using Revonto should speak with their healthcare provider before stopping or replacing their medication, as dantrolene sodium is a muscle relaxant with important medical uses.
The recalled product
- Product
- REVONTO (DANTROLENE SODIUM)
- Brand
- REVONTO
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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