FDA recall D-0984-2022

Product

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-05-10

Report date

2022-06-15

Termination date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0984-2022