NDC 0143-9721
Levofloxacin 500 mg per 100 mL injection, solution
On the label: Hikma Pharmaceuticals USA Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hikma Farmaceutica (portugal), S.a | Terrugem Sintra, Portugal | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 21, 2023 · 9 inspections, 1 with FDA action |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 2007046.1
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levofloxacin: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 500 mg per 100 mL
- Approval
- ANDA ANDA091375
- On the market since
- Sep 16, 2011
- Package NDCs
0143-9721-010143-9721-24- Official label
- DailyMed (National Library of Medicine), updated Mar 28, 2019
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