Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Nov 12, 2014 · Class II · Fresenius Kabi USA, LLC
Defective Container: Vials may be missing stoppers.
Lots: Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Gentamicin: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 40 mg per 1 mL
- Approval
- ANDA ANDA062366
- On the market since
- Aug 10, 2000
- Package NDCs
63323-010-96- Official label
- DailyMed (National Library of Medicine), updated Oct 11, 2024
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