{
  "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": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075240"
        ],
        "brand_name": [
          "LABETALOL HYDROCHLORIDE"
        ],
        "generic_name": [
          "LABETALOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-0125",
          "0409-2267"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LABETALOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "896771"
        ],
        "spl_id": [
          "c1772ea4-65eb-4f27-8e33-3de06278acfe"
        ],
        "spl_set_id": [
          "abfc6b75-1ed5-41f1-0484-4597488237bc"
        ],
        "package_ndc": [
          "0409-2267-20",
          "0409-2267-54",
          "0409-0125-01",
          "0409-0125-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1GEV3BAW9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68296",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1424-2014",
      "product_description": "Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20",
      "product_quantity": "45,448 vials",
      "reason_for_recall": "Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution",
      "recall_initiation_date": "20140516",
      "center_classification_date": "20140708",
      "termination_date": "20170316",
      "report_date": "20140716",
      "code_info": "Lot 36225DD, exp 12/01/2015",
      "more_code_info": ""
    }
  ]
}