Quick answers
- What is Balanced salt solution used for?
- The FDA-approved label (Bss, Alcon Laboratories, Inc., January 25, 2024) says: “For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Balanced salt solution have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Balanced salt solution?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Balanced salt solution been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Balanced salt solution?
- 2 companies list prescription products of Balanced salt solution in the FDA NDC Directory, including Alcon Laboratories, Inc. and B. Braun Medical Inc..
What Balanced salt solution is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.
— FDA label: Bss, Alcon Laboratories, Inc., effective January 25, 2024. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Ophthalmic · Irrigation |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Bss, Balanced Salt |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Alcon Laboratories, Inc.2 products
- B. Braun Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020742 BSS | Alcon | December 10, 1997 | 10, latest November 6, 2015 2015: Manufacturing (CMC) · 2015: Labeling · 2012: Manufacturing (CMC) |
Generic approvals (1)
- ANDA091387B Braun · February 3, 2010
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1033-2022
cGMP deviations: Temperature abuse
BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1034-2022
cGMP deviations: Temperature abuse
BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 806392, 806396 |
|---|---|
| SPL set ID of the quoted label | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea |
| FDA labels (SPL) | 3 |
| FDA applications | NDA020742, 1 ANDA |
| Active ingredients (FDA) | CALCIUM CHLORIDE / MAGNESIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM ACETATE / SODIUM CHLORIDE / SODIUM CITRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bss, Alcon Laboratories, Inc., effective January 25, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →