Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containe
Recalled June 15, 2022 · FDA recall D-0983-2022 · Novartis Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications. · FDA Class III
Units
1,253,862 vials
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications.
Product
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Manufacturer(s)
Novartis Pharmaceuticals Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →