CLASS II Drug recall · Reported 26 Aug 2015 · FDA Enforcement Report
Bromfenac Ophthalmic Solution recalled by Bausch & Lomb
Bausch & Lomb is recalling Bromfenac Ophthalmic Solution, 0.09%, distributed nationwide in the US. The recall was initiated on 17 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1349-2015
- FDA event ID
- 71896
- Recalling firm
- Bausch & Lomb, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2015
- FDA classified
- 20 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 17 Aug 2015 | Recall initiated by company | |
| 20 Aug 2015 | Classified by FDA | +3 days |
| 26 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Where it was distributed
U.S. Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Which lots are affected?
Lot #221211, Expiry: 09/30/2015
Where was it sold?
U.S. Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bausch & Lomb
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalledLotemax | Bausch & Lomb | Potency & Assay | Nationwide |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vit Cutter recalled | Bausch & Lomb | Packaging Defects | 26 states |
Other Bromfenac recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Cardinal HealthBromfenac Ophthalmic Solution 0.09% | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | BromSite (bromfenac ophthalmic solution) recalledBromsite | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution 0.09%, a) bottles recalled | Mayne Pharma Usa | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |