Bausch + Lomb is voluntarily recalling 849,044 tubes of an ophthalmic ointment due to crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. The affected product is Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%. It is packaged in a 1-g tube per carton (professional sample), 1/8-oz. (3.5-g) tube per carton, and 1/4-oz. (7-g) twin pack, two 1/8-oz. (3.5-g) tubes per carton. 

The company also issued a voluntarily recall of 35,253 tubes of sodium chloride hypertonicity ophthalmic ointment, 5%, 1/8-oz. (3.5-g) tube per carton, distributed by Major Pharmaceuticals, also due to crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

The company initiated the Class II recalls on April 10, 2014 in the US (including Puerto Rico), Canada, and Hong Kong. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The notice of the recalls was listed in the US Food and Drug Administration’s Weekly Enforcement Report of July 2, 2014.

Source: FDA (849,044 tubes recall notice) and FDA (35,253 tubes recall notice)