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FDARecalled Jun 4, 2025 · #D-0447-2025

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, G...

Hazard

Class II — temporary health risk

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Description

Failed Impurities/Degradation Specifications Classification: Class II Distribution: US Nationwide

Product details

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
Type
Drugs
Manufacturer
Alembic Pharmaceuticals Limited
Model numbers
7230309, 7230310, 7230311
UPCs