NDC 65282-1505
Sodium Chloride 9 mg per 1 mL injection, solution
On the label: Spectra Medical Deviecs, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Huons Co., Ltd. | Jecheon-si, South Korea | Makes it | Serious problems, FDA actionNov 21, 2025 · 3 inspections, 1 with FDA action |
Recalls
- Apr 2, 2026 · Class II · Huons Co., Ltd.
Lack of Assurance of Sterility
Lots: All lots within expiry
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Chloride Ion: every company that makes it
- Form
- injection, solution, intramuscular; intravenous; subcutaneous
- Strength
- 9 mg per 1 mL
- Approval
- ANDA ANDA206171
- On the market since
- Jul 21, 2017
- Package NDCs
65282-1505-1- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2024
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