June 20, 2019
Bausch & Lomb, a division of Valeant Pharmaceuticals North America, is recalling 170,832 bottles of Lotemax (loteprednol etabonate ophthalmic gel 0.5%) because samples tested out of specification for viscosity, according to the June 19, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Lotemax, 5 g box (NDC 24208-503-07), from lots 282611, 283431, 283441, and 283451 (Exp. 10/19) and 282971, 282981, 283611, 283621, and 283631 (Exp. 11/19). The affected product was distributed throughout the United States.
Bausch & Lomb voluntarily initiated the recall June 17, 2019. The FDA designated the recall Class III on June 19, 2019. Under the recall classification, use of the affected product is not likely to cause harm.
Lotemax is a prescription corticosteroid gel used to treat eye swelling caused by inflammation or injury.