{
  "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": "Wilson",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA074700"
        ],
        "brand_name": [
          "BUMETANIDE"
        ],
        "generic_name": [
          "BUMETANIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0185-0128",
          "0185-0129",
          "0185-0130"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUMETANIDE"
        ],
        "rxcui": [
          "197417",
          "197418",
          "197419"
        ],
        "spl_id": [
          "c6f31ac9-10d1-4d92-882e-836de10e1ce6"
        ],
        "spl_set_id": [
          "05cb961d-ac33-4bcf-b04e-411e496c43c1"
        ],
        "package_ndc": [
          "0185-0128-05",
          "0185-0128-01",
          "0185-0129-05",
          "0185-0129-01",
          "0185-0130-05",
          "0185-0130-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301850128013",
          "0301850129010",
          "0301850130016"
        ],
        "nui": [
          "N0000175366",
          "N0000175590"
        ],
        "pharm_class_pe": [
          "Increased Diuresis at Loop of Henle [PE]"
        ],
        "pharm_class_epc": [
          "Loop Diuretic [EPC]"
        ],
        "unii": [
          "0Y2S3XUQ5H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66791",
      "recalling_firm": "Sandoz Inc",
      "address_1": "4700 Sandoz Dr",
      "address_2": "",
      "postal_code": "27893-8143",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-341-2014",
      "product_description": "Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05",
      "product_quantity": "11,496 bottles (100 count) and 62 bottles (500 count)",
      "reason_for_recall": "Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.",
      "recall_initiation_date": "20131106",
      "center_classification_date": "20131206",
      "termination_date": "20140529",
      "report_date": "20131218",
      "code_info": "Lot #: a) CU6131, b) CW1161",
      "more_code_info": ""
    }
  ]
}