{
  "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 III",
      "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",
          "300544297318"
        ],
        "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": "72234",
      "recalling_firm": "Boehringer Ingelheim Roxane Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0011-2016",
      "product_description": "FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.",
      "product_quantity": "11,110 bottles",
      "reason_for_recall": "CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.",
      "recall_initiation_date": "20150925",
      "center_classification_date": "20151009",
      "termination_date": "20160219",
      "report_date": "20151021",
      "code_info": "Lot #: 559660P, 559661P, Exp 03/17"
    }
  ]
}