# FDA recall D-1275-2019

> **US Worldmeds LLC** · Class II · drug recall initiated 2019-04-25.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1275-2019
- **Recalling firm:** US Worldmeds LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-25
- **Report date:** 2019-05-08
- **Termination date:** 2022-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1275-2019

## Citation

> AI Analytics. FDA recall D-1275-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1275-2019. Source: US FDA. Licensed CC0.

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