Class II
Ongoing
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
This recall is currently active, issued June 4, 2025. It was issued by Alembic Pharmaceuticals Limited.
- Company
- Alembic Pharmaceuticals Limited
- Recall Initiated
- May 7, 2025
- Posted
- June 4, 2025
- Recall Number
- D-0447-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Panchmahal, India
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
US Nationwide
Lot / Code Info
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
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