NDC 0264-7800
Sodium Chloride 0.9 g per 100 mL injection, 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
- Aug 18, 2025 · Class I · B Braun Medical Inc
Presence of Particulate Matter.
Lots: Lot #: V3K770, Exp 1/31/2026 - Aug 4, 2025 · Class II · B Braun Medical Inc
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Lots: Lot #: J5C919, Exp. 08/31/2027 - Jun 16, 2025 · Class II · B Braun Medical Inc
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Lots: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027 - Jul 24, 2024 · Class I · B. Braun Medical Inc
Presence of Particulate Matter
Lots: Lot #: J2L763, J2L764, Exp: 31 March 2025 - Feb 25, 2022 · Class II · B. Braun Medical, Inc.
Lack of sterility assurance: leaking bags
Lots: Lot #: J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023 - Nov 27, 2013 · Class II · B. Braun Medical Inc
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Lots: Lot No. J3D548, expiry: Oct, 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
- Sodium Cation: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 0.9 g per 100 mL
- Approval
- NDA NDA019635
- On the market since
- Dec 31, 2013
- Package NDCs
0264-7800-09- Official label
- DailyMed (National Library of Medicine), updated May 8, 2024
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