Drug recall D-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
Reason for recall
Failed Impurities/Degradation Specifications
Lots and codes
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Recall details
- Recalling firm
- Alembic Pharmaceuticals Limited, Panchmahal, N/A
- Quantity
- N/A
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 7, 2025
Related products
- Bromfenac Ophthalmic Solution 0.09% – drug information
- NDC 62332-508 Bromfenac Ophthalmic Solution 0.09% · Bromfenac Sodium 1.035 mg/mL · Alembic Pharmaceuticals Inc.