NDC 84549-003
Revonto 20 mg per 60 mL injection, powder, lyophilized, for solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Uswm, LLC's NDC 78670-003.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| HAS Healthcare Advanced Synthesis SA | Biasca, Switzerland | Makes the active ingredient | No problems foundFeb 20, 2025 · 4 inspections |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it, tests it, packages it and labels it | No problems foundSep 26, 2025 · 11 inspections |
| Eurofins Biolab Srl | Vimodrone, Italy | Tests it | Problems found, fixed voluntarilySep 13, 2024 · 5 inspections |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dantrolene: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 20 mg per 60 mL
- Approval
- ANDA ANDA078378
- On the market since
- Apr 9, 2021
- Package NDCs
84549-003-67- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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