Class IIReported 2025-06-04

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

Recalled by Alembic Pharmaceuticals Limited

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0447-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-05-07

Reported

2025-06-04

Distribution

US Nationwide

Code Info

Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.