FDA recall D-0983-2022

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.

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-0983-2022