{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077293"
        ],
        "brand_name": [
          "FUROSEMIDE"
        ],
        "generic_name": [
          "FUROSEMIDE"
        ],
        "manufacturer_name": [
          "Leading Pharma, LLC"
        ],
        "product_ndc": [
          "69315-116",
          "69315-117",
          "69315-118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FUROSEMIDE"
        ],
        "rxcui": [
          "197732",
          "310429",
          "313988"
        ],
        "spl_id": [
          "445bfa17-a52c-4492-9dbc-94218b30c1db"
        ],
        "spl_set_id": [
          "b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe"
        ],
        "package_ndc": [
          "69315-116-01",
          "69315-116-10",
          "69315-117-01",
          "69315-117-10",
          "69315-118-01",
          "69315-118-05"
        ],
        "is_original_packager": [
          true
        ],
        "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": "98628",
      "recalling_firm": "Leading Pharma, LLC",
      "address_1": "3 Oak Rd",
      "address_2": "N/A",
      "postal_code": "07004-2903",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0486-2026",
      "product_description": "Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01",
      "product_quantity": "9384 bottles",
      "reason_for_recall": "CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.",
      "recall_initiation_date": "20260320",
      "center_classification_date": "20260421",
      "report_date": "20260429",
      "code_info": "Lots# H03125, H03225, H03325, Exp Date: 2027/08",
      "more_code_info": ""
    }
  ]
}