NDC 0264-7388
Sodium Chloride for Irrigation 0.9 g per 100 mL solution
On the label: B. Braun Medical Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| B. Braun US Pharmaceutical Manufacturing LLC | Irvine, CA, United States | Makes it, packages it and labels it | Serious problems, FDA actionNov 21, 2025 · 13 inspections, 3 with FDA action |
Recalls
- Apr 2, 2026 · Class II · B Braun Medical Inc
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lots: Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. - Aug 26, 2025 · Class II · B Braun Medical Inc
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lots: Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
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
- solution, irrigation
- Strength
- 0.9 g per 100 mL
- Approval
- NDA NDA016733
- On the market since
- Apr 19, 2013
- Package NDCs
0264-7388-500264-7388-60- Official label
- DailyMed (National Library of Medicine), updated Aug 6, 2021
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