Particulate Matter Leads to Recall of Some Allergan Ophthalmic Products
Allergan plc. announced a voluntary recall of specific lots of REFRESH Lacri-Lube, REFRESH PM, FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment USP) 10%/0.2% due to the presence of particular matter.
The recall was based on customer complaints of a small black particle which have led to reported adverse events including eye pain, eye swelling, ocular discomfort, and eye irritation. The small black particle is a part of the cap which can potentially be introduced into the product when the cap is unscrewed.
The specific lots affected of each product may be found on Allergan's website. Retailers, wholesalers, and consumers who currently have any of the affected lots of of REFRESH Lacri-Lube, REFERSH PM, FML 0.1%, and Blephamide 10%/0.2% should immediately stop using the product and return them to Allergan.
REFRESH Lacri-lube and REFRESH PM are indicated for the treatment of dry eyes. FML 0.1% is indicated for ocular inflammation and Blephamide 10%/0.2% is approved for ocular inflammation with infection.
For more information call (877) 674-2087 or visit Allergan.com.