Revonto — Class II drug recall D-1275-2019
Terminated recall by US Worldmeds LLC, reported 2019-05-08, distributed nationwide. Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month sta
| Recall number | D-1275-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Worldmeds LLC, Louisville, KY, United States |
| Recall initiated | 2019-04-25 |
| Classified | 2019-05-10 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2022-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 6,456 vials |
| Reason classes | specification failure |
| NDC | 27505-0003-67 |
| Lot numbers | 17REV01 |
| Expiration dates | 2019-12 |
Product
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
Reason for recall
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
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-1275-2019. 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.