{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cheshire",
      "state": "CT",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "BLA125166"
        ],
        "brand_name": [
          "SOLIRIS"
        ],
        "generic_name": [
          "ECULIZUMAB"
        ],
        "manufacturer_name": [
          "Alexion Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "25682-001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ECULIZUMAB"
        ],
        "rxcui": [
          "700384",
          "700387"
        ],
        "spl_id": [
          "25021c88-95e1-42f0-b895-921526b90642"
        ],
        "spl_set_id": [
          "ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722"
        ],
        "package_ndc": [
          "25682-001-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175575",
          "N0000175974"
        ],
        "pharm_class_epc": [
          "Complement Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Complement Inhibitors [MoA]"
        ],
        "unii": [
          "A3ULP0F556"
        ],
        "upc": [
          "325682001016"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68401",
      "recalling_firm": "Alexion Pharmaceuticals, Inc.",
      "address_1": "352 Knotter Dr",
      "address_2": "N/A",
      "postal_code": "06410-1138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1512-2014",
      "product_description": "Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.",
      "product_quantity": "96,506 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.",
      "recall_initiation_date": "20140602",
      "center_classification_date": "20140805",
      "termination_date": "20150529",
      "report_date": "20140813",
      "code_info": "Lots: 10002-1, 00006-1, Exp 08/14;  10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15"
    }
  ]
}