Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic P...
FDA Recall #D-0447-2025 — Class II — May 7, 2025
Product Description
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
Recalling Firm
Alembic Pharmaceuticals Limited — Panchmahal, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
US Nationwide
Code Information
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated