NDC 62332-508
Bromfenac Ophthalmic Solution 0.09% 1.035 mg per 1 mL solution/ drops
On the label: Alembic Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | Vadodara, India | Makes it | Problems found, fixed voluntarilyFeb 18, 2026 · 2 inspections |
| Gland Pharma Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
Recalls
- May 7, 2025 · Class II · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications
Lots: Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: AGV009
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
- 1.035 mg per 1 mL
- Approval
- ANDA ANDA210560
- On the market since
- Jun 21, 2019
- Package NDCs
62332-508-17- Official label
- DailyMed (National Library of Medicine), updated Feb 5, 2025
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