{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA070434"
        ],
        "brand_name": [
          "FUROSEMIDE"
        ],
        "generic_name": [
          "FUROSEMIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-3294",
          "0054-4297",
          "0054-8297",
          "0054-4299",
          "0054-8299",
          "0054-4301",
          "0054-8301",
          "0054-3298"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FUROSEMIDE"
        ],
        "rxcui": [
          "197730",
          "197731",
          "197732",
          "310429",
          "313988"
        ],
        "spl_id": [
          "bc62ddda-7639-4090-99f0-7dd4d13518f3"
        ],
        "spl_set_id": [
          "9e493331-dddd-496e-abf8-61747fb67aba"
        ],
        "package_ndc": [
          "0054-4297-31",
          "0054-4297-25",
          "0054-8297-25",
          "0054-4299-31",
          "0054-4299-25",
          "0054-8299-25",
          "0054-4301-29",
          "0054-4301-25",
          "0054-8301-25",
          "0054-3298-63",
          "0054-3294-50",
          "0054-3294-46"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300544301251",
          "0300544299251",
          "0300544297257",
          "0300543298637"
        ],
        "nui": [
          "N0000175366",
          "N0000175590"
        ],
        "pharm_class_pe": [
          "Increased Diuresis at Loop of Henle [PE]"
        ],
        "pharm_class_epc": [
          "Loop Diuretic [EPC]"
        ],
        "unii": [
          "7LXU5N7ZO5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76142",
      "recalling_firm": "Roxane Laboratories, Inc.",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0437-2017",
      "product_description": "Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio  43216, NDC 0054-4297-31.",
      "product_quantity": "6493 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.",
      "recall_initiation_date": "20161222",
      "center_classification_date": "20170123",
      "termination_date": "20171218",
      "report_date": "20170201",
      "code_info": "Lot# 660833A, Exp 08/31/18"
    }
  ]
}