Ophthalmic Solution Recalled

Aurobindo Pharma USA Inc is recalling 3 lots of moxifloxacin ophthalmic solution for failing to meet impurity specifications, according to the February 23, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects moxifloxacin ophthalmic solution .5%, in 3-mL bottles (NDC 65862-840-03), from lots CMF210001, CMF210003, and CMF210004 (Exp. 6/23). The product was made in India and distributed by Aurobindo Pharma USA, East Windsor, NJ, throughout the United States.

Aurobindo Pharma USA voluntarily initiated the recall January 14, 2022. On February 14, 2022, the FDA designated the recall Class II, signaling use of the solution could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Moxifloxacin ophthalmic solution is a prescription quinolone antibiotic used to treat eye infections.