Allergan announces voluntary recall due to particulate matter

Allergan has initiated a voluntary recall of four topical ocular drugs because of customer complaints regarding particulate matter, according to a press release issued by the FDA.

The recall affects specific lots of Refresh Lacri-Lube and Refresh P.M. ointments (mineral oil and white petrolatum), FML ointment (fluorometholone) and Blephamide (sulfacetamide sodium and prednisolone acetate).

As detailed in the release, a group of customers complained of a small black particle that can be introduced into the product. The particle is part of the cap, but can be created by unscrewing the cap. Customers reported various adverse events, including foreign body, irritation, discomfort, swelling and blurry vision.

Allergan is currently in the process of contacting wholesalers and retailers so they can return the product, as detailed in the release. Consumers are asked to stop using any affected products and return them to Allergan.