Allergan has announced a voluntary recall of its REFRESH Lacri-Lube 3.5g and 7g for dry eye, FML@ (fluorometholone ophthalmic ointment) 0.1 percent (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide@ (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 percent/0.2 percent sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by unscrewing the cap of the aluminum tube, and potentially introduced into the product. Reported adverse events include:
- Foreign body in eye
- Eye irritation
- Ocular discomfort
- Product contamination
- Superficial eye injury
- Eye pain
- Eye swelling
- Burry vision
Specific lots are being voluntarily recalled in the interest of patient safety. If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. Allergan is also contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
