Allergan Recalls Eye Medication Due to Cap Particles

August 24, 2015

Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

Allergan is conducting a voluntary recall down to consumer level of specific lots of its 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. Allergan chose to initiate this recall based on a small number of customer complaints that reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube and can potentially be introduced into the product. Specific lots are being voluntarily recalled in the interest of patient safety. 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).

Allergan is 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. The company is asking consumers who currently have product from any of the affected lots of to stop using the product and return it to Allergan. Affected lot numbers are listed on the company’s website.

Source: Allergan