Allergan Initiates Recall of Select Lots of Eye Care Products
Allergan plc, has initiated a voluntary recall to the consumer level of specific lots of its Refresh Lacri-LubeÂ® 3.5 g and 7 g for dry eye,Refresh P.M.Â® 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. 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 potentially introduced into the product.
Reported adverse events include foreign body in the eye (12 events), eye irritation (2), ocular discomfort (2), product contamination (2), superficial injury of eye (2), eye pain (1), eye swelling (1) and blurred vision (1).
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 P.M. Â®, FML (fluorometholone ophthalmic ointment) 0.1%, Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. 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-LubeÂ®, Refresh P.M., FML (fluorometholone ophthalmic ointment) 0.1% , Blephamide (sulfacetamide sodium or prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, to stop using the product and return it to Allergan.