Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster
Summary
The FDA issued a Class II for Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: A by ALEMBIC PHARMACEUTICALS, INC.. Reason: Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing..
Details
Source
Drug Recall
External ID
6b30556b-40dd-4f7b-a55f-b065bf1f6033
Action Date
2026-04-08
Status
Ongoing
Category
drug
Product Description
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Lot/Code Info: Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-18
Company
Bedminster, NJ
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 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 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, INC.) 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, INC. have FDA actions?
ALEMBIC PHARMACEUTICALS, INC. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "6b30556b-40dd-4f7b-a55f-b065bf1f6033" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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