Allergan issues voluntary nationwide recall in the US of specific lots of eye drugs because of particulate matter

Allergan is conducting a voluntary recall down to consumer level of specific lots of its 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. 

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 (55 in total) 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 FDA of this voluntary recall. The recall only applies to specific lots of the Refresh Lacri-Lube, Refresh P.M., 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.