Quick answers
- What is Bss?
- Bss is a brand name of Balanced salt solution, a prescription medicine. The FDA NDC Directory lists 2 Bss products in 1 strength and form.
- Who makes Bss?
- Alcon holds the FDA application for Bss (NDA020742, approved December 10, 1997).
- Is there a generic or store brand of Bss?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Bss product, 1 of them generic. Ask your pharmacist whether one is right for you.
- Has Bss been recalled?
- FDA enforcement reports list 2 recalls of Bss products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Bss is
Each Bss 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.
Balanced salt solution · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| calcium chloride 0.48 mg/mL · magnesium chloride 0.3 mg/mL · potassium chloride 0.75 mg/mL · sodium acetate 3.9 mg/mL · sodium chloride 6.4 mg/mL · sodium citrate 1.7 mg/mL solution (ophthalmic) | Bss | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Balanced salt solution →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020742 | Alcon | December 10, 1997 | 2 |
Companies that list Bss
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Bss products.
- Alcon Laboratories, Inc.2 products
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 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
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.