{
  "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": "Lexington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA125277"
        ],
        "brand_name": [
          "KALBITOR"
        ],
        "generic_name": [
          "ECALLANTIDE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "47783-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ECALLANTIDE"
        ],
        "rxcui": [
          "884698",
          "884702"
        ],
        "spl_id": [
          "1992039f-246f-4057-899b-987d45df152f"
        ],
        "spl_set_id": [
          "f56aec67-c662-477c-b866-bfc23e8809cf"
        ],
        "package_ndc": [
          "47783-101-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000192750",
          "N0000184151"
        ],
        "pharm_class_epc": [
          "Plasma Kallikrein Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Kallikrein Inhibitors [MoA]"
        ],
        "unii": [
          "5Q6TZN2HNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76761",
      "recalling_firm": "Shire",
      "address_1": "300-400 Shire Way",
      "address_2": "N/A",
      "postal_code": "02421-2101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Kuwait",
      "recall_number": "D-0625-2017",
      "product_description": "Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton,  Rx Only,  Dynax Corp., Burlington, MA. NDC47783-101-01",
      "product_quantity": "3, 536 cartons (3 vials per carton)",
      "reason_for_recall": "Presence of Particulate Matter: Glass",
      "recall_initiation_date": "20170317",
      "center_classification_date": "20170331",
      "termination_date": "20210525",
      "report_date": "20170412",
      "code_info": "Lot #: A1500009, Exp. Jan 31, 2019"
    }
  ]
}