Revonto dantrolene sodium injection recalled due to temperature abuse during distribution
McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription drug due to cGMP violations related to temperature abuse during storage and distribution. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity category.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Revonto (dantrolene sodium for injection), 20 mg/vial, supplied in 6-vial boxes. The recall affects 16 cartons distributed nationwide.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations related to temperature abuse during product storage and distribution.
Healthcare facilities and pharmacies that received this product should identify affected units using the distribution dates provided in their recall notices from the manufacturer. McKesson was unable to identify specific lot numbers associated with particular customers.
Consumers and healthcare providers should consult with their pharmacy or healthcare provider regarding the recalled product and whether a replacement or further guidance is needed.
The recalled product
- Product
- Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Prescription
- Hazard
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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