FDA Drug recall D-0984-2022
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-9…
- FDA Drug
- Class III
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class III recall of Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-9… by Novartis Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0984-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-05-10 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| ndc | 0078-0911-05 |
|---|---|
| ndc | 0078-0911-12 |
| ndc | 0078-0911-95 |
| ndc | 0078-0911-94 |
| code_info | Lot #: a) and b) 20DJ3, Exp. Date 03/2023. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0984-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.