FDA recall D-0985-2022

Novartis Pharmaceuticals Corporation · Class III · drug

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.

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-05-10
Report date: 2022-06-15
Termination date: 2024-02-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0985-2022