NDC 0517-1045
Levocarnitine 200 mg per 1 mL injection, solution
On the label: American Regent, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | New Albany, OH, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilyJan 29, 2026 · 5 inspections |
Recalls
- Apr 16, 2026 · Class III · American Regent, Inc.
Labeling: Missing Label
Lots: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levocarnitine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 200 mg per 1 mL
- Approval
- ANDA ANDA075861
- On the market since
- Jun 21, 2023
- Package NDCs
0517-1045-010517-1045-05- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2023
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