Quick answers
- What is Sodium Chloride for Irrigation?
- Sodium Chloride for Irrigation is a brand name of Sodium chloride, a prescription medicine. The FDA NDC Directory lists 1 Sodium Chloride for Irrigation product in 1 strength and form.
- Who makes Sodium Chloride for Irrigation?
- B Braun holds the FDA application for Sodium Chloride for Irrigation (NDA016733, approved August 12, 1970).
- Is there a generic or store brand of Sodium Chloride for Irrigation?
- Other products of Sodium chloride are listed with the FDA, but none in exactly the same strength and form as a Sodium Chloride for Irrigation product.
- Has Sodium Chloride for Irrigation been recalled?
- FDA enforcement reports list 2 recalls of Sodium Chloride for Irrigation products; the newest started April 2, 2026. A recall usually concerns specific lots, not every product.
What Sodium Chloride for Irrigation is
Each Sodium Chloride for Irrigation product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Sodium chloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sodium chloride 0.9% solution (irrigation) | Sodium Chloride for Irrigation | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sodium chloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA016733 | B Braun | August 12, 1970 | 1 |
Companies that list Sodium Chloride for Irrigation
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sodium Chloride for Irrigation products.
- B. Braun Medical Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 2, 2026 · Class II · Ongoing · D-0497-2026
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. — B BRAUN MEDICAL INC
-
August 26, 2025 · Class II · Ongoing · D-0653-2025
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60. — B BRAUN MEDICAL INC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.