Drug 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
D-0447-2025
Product summary
- Event
- Event 96836
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0447-2025
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications