Allergan plc has issued a voluntary consumer level recall of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh PM 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1 per cent (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 per cent/0.2 per cent 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 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).

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 US Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of the Refresh Lacri-Lube, Refresh PM, FML (fluorometholone ophthalmic ointment) 0.1 per cent, Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 per cent/0.2 per cent. This recall does not affect any other Refresh or Allergan product.

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 Refresh Lacri-Lube, Refresh PM, FML (fluorometholone ophthalmic ointment) 0.1 per cent, Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 per cent/0.2 per cent, to stop using the product and return it to Allergan.