Allergan recalls eye treatment medications

Some of the medications contain a small black particle

By James Limbach of ConsumerAffairs

Allergan is recalling the following eye treatment medications:

• REFRESH Lacri-Lube 3.5-g and 7-g for dry eye
• REFRESH P.M. 3.5-g for dry eye
• FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5-g) and
• Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5-g.

The recall is based on a small number of customer complaints which reported a small black particle at the time of use. This particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product.

Reported adverse events include foreign body in eye (12), eye irritation (2), ocular discomfort (2), product contamination (2), superficial injury of eye (2), eye pain (1), eye swelling (1) and vision blurred (1).

The following products are being recalled:

Consumers who currently have the recalled products should stop using the product and return them to Allergan.