Alembic Bromfenac Ophthalmic Solution 0.07% Class II Recall for Failed Impurities/Degradation Specifications

ALEMBIC PHARMACEUTICALS, INC.

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II 98647 · 20260408 · Ongoing · Voluntary: Firm initiated

Product

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 Limi...

Reason for Recall

Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.

Affected Lot Numbers / Codes

Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.

Firm Notification Method

Letter

Distribution

Nationwide in the USA

Initiated

20260318

FDA Classified

20260331

Product Registration

Brand: BROMFENAC SODIUM

Manufacturer: Alembic Pharmaceuticals Inc.

Application: ANDA214340

NDC: 62332-583

Drug Label Context (from openFDA)

The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.

Indications & Usage

1 INDICATIONS AND USAGE Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days post-surgery. ( 2.1 ) 2.1 Recommended Dosage Apply one drop to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, ...

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical t...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac ophthalmic solution 0.07% is supplied in a white Opaque LDPE bottle with White Opaque LDPE nozzle and gray HDPE cap as follows: • NDC 62332-583-03 3 mL in a 5 mL bottle Storage Store at 15ºC to 25ºC (59ºF to 77ºF). After opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle.

Sources: openFDA · Raw JSON