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.
Reason for recall: Failed Impurities/Degradation Specifications.
Recall initiated: 20220510
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated