{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021908"
        ],
        "brand_name": [
          "AMITIZA"
        ],
        "generic_name": [
          "LUBIPROSTONE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "64764-080",
          "64764-240"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LUBIPROSTONE"
        ],
        "rxcui": [
          "616578",
          "617768",
          "794639",
          "794641"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "d474ac6a-444d-4aa6-9986-24be6fcf811d"
        ],
        "package_ndc": [
          "64764-080-60",
          "64764-080-40",
          "64764-240-60",
          "64764-240-10",
          "64764-240-40"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175573",
          "N0000175456"
        ],
        "pharm_class_epc": [
          "Chloride Channel Activator [EPC]"
        ],
        "pharm_class_moa": [
          "Chloride Channel Activators [MoA]"
        ],
        "unii": [
          "7662KG2R6K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81518",
      "recalling_firm": "Takeda Development Center Americas, Inc.",
      "address_1": "1 Takeda Pkwy",
      "address_2": "4034BB1",
      "postal_code": "60015-5713",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 32 distributors throughout the United States.",
      "recall_number": "D-0286-2019",
      "product_description": "AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States.  NDC 64764-080-60",
      "product_quantity": "69,075 60-count bottles (4,144,500 capsules)",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.",
      "recall_initiation_date": "20181106",
      "center_classification_date": "20181128",
      "termination_date": "20190620",
      "report_date": "20181121",
      "code_info": "Lot # 3098628-61, exp. date 02/28/2021",
      "more_code_info": ""
    }
  ]
}