Bromfenac Ophthalmic Solution 0.09% Solution/ Drops
FDA Recall NDC 62332-508
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bromfenac Ophthalmic Solution 0.09% (NDC 62332-508). A significant event, classified as Class II, was initiated on May 07, 2025 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications
May 07, 2025
Jun 04, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96836
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
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
Batch or Lot Expiration Information
Lot# Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Affected Packages Involved in this Recall
62332-508-17Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
152 CARTON
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Batch or Lot Expiration Information
Lot# AGV009
Affected Packages Involved in this Recall
62332-508-17Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
