Drug product
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
D-0984-2022
Product summary
- Event
- Event 90176
- Status
- Terminated
- Classification
- Class III
- Quantity
- 279,179 vials
- Official record key
drug-enforcement:D-0984-2022
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: a) and b) 20DJ3, Exp. Date 03/2023.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications