NDC 49708-754
Bromsite 0.075% 0.76 mg per 1 mL solution/ drops
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Woodstock Sterile Solutions, Inc. | Woodstock, IL, United States | Makes it, tests it, packages it and labels it | No problems foundOct 13, 2022 · 11 inspections |
Recalls
- Jan 24, 2019 · Class II · Sun Pharmaceutical Industries, Inc.
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Lots: Lot #: V18E01, Exp. 05/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bromfenac: every company that makes it
- Form
- solution/ drops, ophthalmic
- Strength
- 0.76 mg per 1 mL
- Approval
- NDA NDA206911
- On the market since
- May 1, 2016
- Package NDCs
49708-754-41- Official label
- DailyMed (National Library of Medicine), updated Jan 8, 2026
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