LIFITEGRAST Recall D-0985-2022
Description: 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.
LIFITEGRAST Recall D-0985-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0985-2022 |
| Event ID | 90176 |
| Brand | XIIDRA |
| Generic Name | LIFITEGRAST |
| Manufacturer | LIFITEGRAST |
| Original Package? | 1 |
| Active Substance | LIFITEGRAST |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide within the United States |
| Quantity | 279,179 vials |
| Recall Reason | Failed Impurities/Degradation Specifications. |
| Drug Classification | Class III |
| Drug Code Info | 20220615 |
| Product NDC | 54092-606 |
| Product NUI | N0000192701 N0000192700 |
| Pharma Class (EPC) | Lymphocyte Function-Associated Antigen-1 Antagonist [EPC] |
| Recall Initiation Date | 20220510 |
| Report Date | 20220615 |
| Classification Date | 20220606 |
| Address | 1 Health Plz East Hanover, NJ 07936-1016 United States |
| Recalling Firm | Novartis Pharmaceuticals Corporation |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 038E5L962W |
| Drug Application Number | NDA208073 |
| Structured Product Labeling (SPL ID) | 2648ebbb-5b5e-4497-adc2-db90088ba884 |
| Structured Product Labeling (SPL Set ID) | ac09d19a-e321-4556-8a5c-66bd27cb6533 |
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