{
  "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": "Earth City",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021742"
        ],
        "brand_name": [
          "BYSTOLIC"
        ],
        "generic_name": [
          "NEBIVOLOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "0456-1402",
          "0456-1405",
          "0456-1410",
          "0456-1420"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NEBIVOLOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "387013",
          "751612",
          "751616",
          "751618",
          "751620",
          "751623",
          "827073",
          "827075"
        ],
        "spl_id": [
          "0096cdf0-43e6-4128-8990-aed7e1fab83f"
        ],
        "spl_set_id": [
          "8b8ad213-1dc8-454e-a524-075685c0e1a8"
        ],
        "package_ndc": [
          "0456-1402-30",
          "0456-1402-90",
          "0456-1402-01",
          "0456-1402-63",
          "0456-1405-30",
          "0456-1405-90",
          "0456-1405-01",
          "0456-1405-63",
          "0456-1410-30",
          "0456-1410-90",
          "0456-1410-01",
          "0456-1410-63",
          "0456-1420-30",
          "0456-1420-90",
          "0456-1420-01",
          "0456-1420-63"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304561405909",
          "0304561402304",
          "0304561420902",
          "0304561410903"
        ],
        "unii": [
          "JGS34J7L9I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68246",
      "recalling_firm": "Forest Pharmaceuticals Inc",
      "address_1": "13600 Shoreline Dr",
      "address_2": "N/A",
      "postal_code": "63045-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1348-2014",
      "product_description": "Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30",
      "product_quantity": "21,875 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.",
      "recall_initiation_date": "20140512",
      "center_classification_date": "20140522",
      "termination_date": "20160105",
      "report_date": "20140528",
      "code_info": "Lot: A287945, Exp: 08/2015"
    }
  ]
}