Bausch & Lomb recalls Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Ph…

Recall date

June 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1396-2019

FDA classification

Class III

Brand / firm

Bausch & Lomb

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Failed Stability Specifications: Out of specification for viscosity.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.