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.

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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.

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