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.
D-0985-2022
Product summary
- Event
- Event 90176
- Status
- Terminated
- Classification
- Class III
- Quantity
- 279,179 vials
- Official record key
drug-enforcement:D-0985-2022
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications