{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209916"
        ],
        "brand_name": [
          "BUMETANIDE"
        ],
        "generic_name": [
          "BUMETANIDE"
        ],
        "manufacturer_name": [
          "Upsher-Smith Laboratories, LLC"
        ],
        "product_ndc": [
          "0832-0540",
          "0832-0541",
          "0832-0542"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUMETANIDE"
        ],
        "rxcui": [
          "197417",
          "197418",
          "197419"
        ],
        "spl_id": [
          "d53166d9-64ca-4b76-81a7-b70a60c53b12"
        ],
        "spl_set_id": [
          "ff5dc8c6-b2f2-41d3-8e56-a953aa721b59"
        ],
        "package_ndc": [
          "0832-0540-11",
          "0832-0541-11",
          "0832-0541-10",
          "0832-0542-11",
          "0832-0542-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0308320540115",
          "0308320541112"
        ],
        "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": "81174",
      "recalling_firm": "Upsher Smith Laboratories, Inc.",
      "address_1": "6701 Evenstad Dr N",
      "address_2": "N/A",
      "postal_code": "55369-6026",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA, Puerto Rico and Guam",
      "recall_number": "D-0281-2019",
      "product_description": "Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by:  Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11",
      "product_quantity": "29,080 bottles",
      "reason_for_recall": "Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.",
      "recall_initiation_date": "20180919",
      "center_classification_date": "20181121",
      "termination_date": "20200930",
      "report_date": "20181031",
      "code_info": "Lot#:  372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020"
    }
  ]
}