{
  "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": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020649"
        ],
        "brand_name": [
          "EDEX"
        ],
        "generic_name": [
          "ALPROSTADIL"
        ],
        "manufacturer_name": [
          "Endo USA, Inc."
        ],
        "product_ndc": [
          "52244-010",
          "52244-020",
          "52244-040"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRACAVERNOUS"
        ],
        "substance_name": [
          "ALPROSTADIL"
        ],
        "rxcui": [
          "1234236",
          "1234238",
          "1234239",
          "1234240",
          "1234241",
          "1234242"
        ],
        "spl_id": [
          "7c40fd8e-69c9-4f07-87e8-0ab6ebfe818e"
        ],
        "spl_set_id": [
          "e8b8ec8d-1318-43e4-a182-446e9f9579de"
        ],
        "package_ndc": [
          "52244-010-02",
          "52244-010-06",
          "52244-020-02",
          "52244-020-06",
          "52244-040-02",
          "52244-040-06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000009059",
          "N0000175454",
          "N0000180189",
          "N0000000106",
          "M0017805",
          "N0000009911"
        ],
        "pharm_class_pe": [
          "Genitourinary Arterial Vasodilation [PE]",
          "Venous Vasodilation [PE]"
        ],
        "pharm_class_epc": [
          "Prostaglandin Analog [EPC]",
          "Prostaglandin E1 Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Prostaglandin Receptor Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Prostaglandins [CS]"
        ],
        "unii": [
          "F5TD010360"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76542",
      "recalling_firm": "Endo Pharmaceuticals, Inc.",
      "address_1": "1400 Atwater Drive",
      "address_2": "N/A",
      "postal_code": "19355",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0512-2017",
      "product_description": "Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.",
      "product_quantity": "5,086 cartridges",
      "reason_for_recall": "Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.  ok thanks",
      "recall_initiation_date": "20170222",
      "center_classification_date": "20170303",
      "termination_date": "20180612",
      "report_date": "20170315",
      "code_info": "Lot #: 207386, Exp. May 2019"
    }
  ]
}