Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0985-2022
Event ID90176
BrandXIIDRA
Generic NameLIFITEGRAST
ManufacturerLIFITEGRAST
Original Package?1
Active SubstanceLIFITEGRAST
Drug RouteOPHTHALMIC
DistributionNationwide within the United States
Quantity279,179 vials
Recall ReasonFailed Impurities/Degradation Specifications.
Drug ClassificationClass III
Drug Code Info20220615
Product NDC54092-606
Product NUIN0000192701 N0000192700
Pharma Class (EPC)Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]
Recall Initiation Date20220510
Report Date20220615
Classification Date20220606
Address1 Health Plz
East Hanover, NJ 07936-1016
United States
Recalling FirmNovartis Pharmaceuticals Corporation
Initial Notification Letter
Unique Ingredient Identifier038E5L962W
Drug Application NumberNDA208073
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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