Allergan recalled three types of ointments used to treat various eye conditions because small black particles were found floating in the products.
The Allergan recall includes specific lots of Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Specific lot numbers can be found here.
The recall was initiated after customer complaints about small black particles in the ointments. Allergan says the black particle is part of the cap and can be created when the cap is unscrewed from the aluminum tube. If these particles get into the eye, they have the potential to cause adverse effects including eye pain, eye swelling, ocular discomfort or eye irritation.
Consumers who have affected eye ointments should stop using them and return them and contact their physician or health care provider if they have experienced any problems that may be related to use of the ointment.
Any side effects while using these eye ointments should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.