Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers
Recalled June 15, 2022 · FDA recall D-0982-2022 · Novartis Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications. · FDA Class III
Units
1,187,092 vials
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications.
Product
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
Manufacturer(s)
Novartis Pharmaceuticals Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →