{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA205874"
        ],
        "brand_name": [
          "AURYXIA"
        ],
        "generic_name": [
          "FERRIC CITRATE"
        ],
        "manufacturer_name": [
          "Akebia Therapeutics, Inc."
        ],
        "product_ndc": [
          "59922-631"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TETRAFERRIC TRICITRATE DECAHYDRATE"
        ],
        "rxcui": [
          "1594680",
          "1596023"
        ],
        "spl_id": [
          "79cb63af-94fa-4f49-91d3-543c0058cd4e"
        ],
        "spl_set_id": [
          "aadd18e0-3752-11e4-8510-0800200c9a66"
        ],
        "package_ndc": [
          "59922-631-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Q91187K011"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78773",
      "recalling_firm": "Keryx Biopharmaceuticals, Inc.",
      "address_1": "1 Marina Park Dr Fl 12",
      "address_2": "N/A",
      "postal_code": "02210-1832",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide in the USA",
      "recall_number": "D-0133-2018",
      "product_description": "Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01",
      "product_quantity": "2,488 200-bottles",
      "reason_for_recall": "Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.",
      "recall_initiation_date": "20171212",
      "center_classification_date": "20171226",
      "termination_date": "20181001",
      "report_date": "20180103",
      "code_info": "Lot # AH3842"
    }
  ]
}