{
  "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": "66771",
      "recalling_firm": "Alexion Pharmaceuticals, Inc.",
      "address_1": "352 Knotter Dr",
      "address_2": "",
      "postal_code": "06410-1138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide, Puerto Rico, Jamaica, and Grenada.",
      "recall_number": "D-1049-2014",
      "product_description": "Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 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": "21,661 vials",
      "reason_for_recall": "Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.",
      "recall_initiation_date": "20131104",
      "center_classification_date": "20140130",
      "termination_date": "20150302",
      "report_date": "20140205",
      "code_info": "Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15",
      "more_code_info": ""
    }
  ]
}