FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Postmarket Safety / Commercial Operations

Allergan Recalls 55 Lots of Eye Ointment

Sept. 1, 2015

Allergan is recalling 55 lots of four types of eye ointment that could contain a small black particle from the product’s cap.

The company initiated the recall following customer complaints of product contamination and particles being introduced into the eyes. According to Allergan, the particles eroded from the cap when it was unscrewed from the aluminum tube.

The recall involves Refresh Lacri-Lube and P.M. lubricants for dry eye, FML (fluorometholone) anti-inflammatory and antibacterial/corticosteroid combination Blephamide (sulfacetamide sodium and prednisolone acetate).

The affected products have expiration dates ranging from April 2017 to March 2018. The Dublin, Ireland, drugmaker did not say when the products were produced or where they were distributed.

The company could not be reached for comment by press time. — Jonathon Shacat