FDA recall D-1396-2019

Bausch & Lomb · Class III · drug

Product

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.

Reason for recall

Failed Stability Specifications: Out of specification for viscosity.

Distribution

Nationwide in the U.S.

Key facts

Status: Terminated
Initiation date: 2019-06-17
Report date: 2019-06-19
Termination date: 2021-09-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1396-2019