{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Hanover",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA208073"
        ],
        "brand_name": [
          "XIIDRA"
        ],
        "generic_name": [
          "LIFITEGRAST"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0911"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "LIFITEGRAST"
        ],
        "rxcui": [
          "1801835",
          "1801840"
        ],
        "spl_id": [
          "3cabbaea-c2bf-971c-e063-6394a90a4931"
        ],
        "spl_set_id": [
          "8589d376-ac10-4ddb-9c53-2e0c8d5675c4"
        ],
        "package_ndc": [
          "0078-0911-05",
          "0078-0911-12",
          "0078-0911-95",
          "0078-0911-94"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000192701",
          "N0000192700"
        ],
        "pharm_class_epc": [
          "Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"
        ],
        "unii": [
          "038E5L962W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90176",
      "recalling_firm": "Novartis Pharmaceuticals Corporation",
      "address_1": "1 Health Plz",
      "address_2": "",
      "postal_code": "07936-1016",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0982-2022",
      "product_description": "Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.",
      "product_quantity": "1,187,092 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications.",
      "recall_initiation_date": "20220510",
      "center_classification_date": "20220606",
      "termination_date": "20240228",
      "report_date": "20220615",
      "code_info": "Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8,  20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66,  20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22, 20S44, 20S94, Exp. Date 10/2023; 20SA6, 20SA7, 20SE0, Exp. Date 10/2023, 20TE2, 20TG5, Exp. Date 11/2023.",
      "more_code_info": ""
    }
  ]
}