CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
BromSite (bromfenac ophthalmic solution) recalled
Sun Pharmaceutical Industries is recalling BromSite (bromfenac ophthalmic solution) 0.075%, distributed nationwide in the US. The recall was initiated on 24 Jan 2019 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-0422-2019
- FDA event ID
- 81958
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Brand
- Bromsite
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2019
- FDA classified
- 30 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 24 Jan 2019 | Recall initiated by company | |
| 30 Jan 2019 | Classified by FDA | +6 days |
| 6 Feb 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
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
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Which lots are affected?
Lot #: V18E01, Exp. 05/2020
Where was it sold?
Nationwide within the United States
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.
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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 | 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 |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Bausch & Lomb | Bausch & Lomb | Sterility | Nationwide |