Recall D-0447-2025

US Class II Ongoing · initiated 2025-05-07

Recalling firm

Alembic Pharmaceuticals Limited

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

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