{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Madison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761180"
        ],
        "brand_name": [
          "ADBRY"
        ],
        "generic_name": [
          "TRALOKINUMAB-LDRM"
        ],
        "manufacturer_name": [
          "LEO Pharma Inc."
        ],
        "product_ndc": [
          "50222-346",
          "50222-350"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "TRALOKINUMAB"
        ],
        "rxcui": [
          "2589378",
          "2589384",
          "2686061",
          "2686065"
        ],
        "spl_id": [
          "8abedac8-f75e-42a0-8591-10fabcf41fb5"
        ],
        "spl_set_id": [
          "d8020b69-3001-44e2-9b5d-5f93d9aaf6e1"
        ],
        "package_ndc": [
          "50222-346-01",
          "50222-346-02",
          "50222-346-22",
          "50222-346-04",
          "50222-346-91",
          "50222-346-92",
          "50222-350-00",
          "50222-350-01",
          "50222-350-02",
          "50222-350-90",
          "50222-350-91"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193985",
          "N0000193986"
        ],
        "pharm_class_epc": [
          "Interleukin-13 Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Interleukin-13 Antagonists [MoA]"
        ],
        "unii": [
          "GK1LYB375A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98401",
      "recalling_firm": "LEO PHARMA INC",
      "address_1": "7 Giralda Farms",
      "address_2": "N/A",
      "postal_code": "07940-1051",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0339-2026",
      "product_description": "Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors,  NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,",
      "product_quantity": "11,407 units",
      "reason_for_recall": "Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.",
      "recall_initiation_date": "20260210",
      "center_classification_date": "20260223",
      "report_date": "20260304",
      "code_info": "Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027."
    }
  ]
}