The Recall Desk
HighFDA (Drugs)·D-1080-2022·Announced 2022-06-15

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.

What this means for you

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
  • temperature-abuse

Distribution

Distributed nationwide across the United States.

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