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FDAMay 10, 2022drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications.

What to do

FDA enforcement status: Terminated

Brands named

novartis pharmaceuticalsnovartis

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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