Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Marion, NC, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| Syngene International Limited | Bengaluru, India | Tests it | No problems foundFeb 20, 2025 · 4 inspections |
Recalls
- Apr 12, 2016 · Class II · Baxter Healthcare Corp.
Discoloration: presence of atypical yellow discoloration of the solution .
Lots: Lot # C989954, Exp 9/17 - Jun 16, 2014 · Class II · Baxter Healthcare Corp.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Lots: Lot #: C926923, Exp 01/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Esmolol: every company that makes it
- Form
- injection, intravenous
- Strength
- 10 mg per 1 mL
- Approval
- NDA NDA019386
- On the market since
- Dec 31, 1986
- Package NDCs
10019-115-0110019-115-39- Official label
- DailyMed (National Library of Medicine), updated Mar 14, 2025
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