Data Foundry

Drug recalls 2022

Revonto — Class II drug recall D-1080-2022

Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-06-15, distributed nationwide. cGMP deviations: Temperature abuse

Recall numberD-1080-2022
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States
Recall initiated2022-04-13
Classified2022-06-09
Reported by FDA2022-06-15
Terminated2023-11-30
DistributedNationwide (US)
Reason classescgmp, temperature control
NDC27505-0003-67

Product

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

Reason for recall

cGMP deviations: Temperature abuse

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1080-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.