CLASS II Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Bromfenac Ophthalmic Solution recalled by Apotex
Apotex is recalling Bromfenac Ophthalmic Solution 0.09%, distributed nationwide in the US. The recall was initiated on 25 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
Timeline
| 25 Aug 2015 | Recall initiated by company | |
| 9 Oct 2015 | Classified by FDA | +45 days |
| 21 Oct 2015 | Published in enforcement report | +12 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%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Which lots are affected?
Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
Where was it sold?
Nationwide
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 Apotex
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
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 Bausch & Lomb | Bausch & Lomb | Sterility | Nationwide |