Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vi…

Recall date

May 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0985-2022

FDA classification

Class III

Brand / firm

Novartis Pharmaceuticals Corporation

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Impurities/Degradation Specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.