NDC 65219-282
Sodium chloride 9 mg per 1 mL injection, solution
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Wilson, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyFeb 13, 2026 · 5 inspections |
| Fresenius Medical Care North America | Ogden, UT, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionMar 6, 2026 · 8 inspections, 1 with FDA action |
Recalls
- Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 9 mg per 1 mL
- Approval
- ANDA ANDA207310
- On the market since
- Jun 30, 2023
- Package NDCs
65219-282-0165219-282-10- Official label
- DailyMed (National Library of Medicine), updated Apr 25, 2025
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