Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., B
Summary
The FDA issued a Class II for Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactur by Alembic Pharmaceuticals Limited. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0447-2025
Action Date
2025-06-04
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Quantity Affected: N/A
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-07
Company
Panchmahal, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 50 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alembic Pharmaceuticals Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alembic Pharmaceuticals Limited have FDA actions?
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0447-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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