{
  "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": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": [
          "c2ca8178-4da1-42d1-a8b9-ff66dca82649"
        ],
        "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": "82830",
      "recalling_firm": "MALLINCKRODT PHARMACEUTICALS",
      "address_1": "1425 Us Highway 206",
      "address_2": "N/A",
      "postal_code": "07921-2653",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-1294-2019",
      "product_description": "Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60",
      "product_quantity": "89,808 bottles",
      "reason_for_recall": "Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.",
      "recall_initiation_date": "20190513",
      "center_classification_date": "20190523",
      "termination_date": "20230717",
      "report_date": "20190529",
      "code_info": "Lot #: 3229691-61, Exp 01/2022"
    }
  ]
}