Recalls / Class II
Class IID-0447-2025
Product
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
- Brand name
- Bromfenac Ophthalmic Solution 0.09%
- Generic name
- Bromfenac Ophthalmic Solution 0.09%
- Active ingredient
- Bromfenac Sodium
- Route
- Ophthalmic
- NDC
- 62332-508
- FDA application
- ANDA210560
- Affected lot / code info
- Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Alembic Pharmaceuticals Limited
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A, Panchmahal, N/A N/A, India
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2025-05-07
- FDA classified
- 2025-05-27
- Posted by FDA
- 2025-06-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0447-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.