Product: Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), 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