{
  "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": "Mcpherson",
      "state": "KS",
      "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",
          "0409-2267-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1GEV3BAW9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79238",
      "recalling_firm": "Hospira Inc. A Pfizer Company",
      "address_1": "1776 Centennial Dr",
      "address_2": "N/A",
      "postal_code": "67460-9301",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0576-2018",
      "product_description": "Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL  60045, NDC 0409-2267-25.",
      "product_quantity": "a) 137,975 vials; b) 40,143 vials",
      "reason_for_recall": "Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.",
      "recall_initiation_date": "20180220",
      "center_classification_date": "20180302",
      "termination_date": "20200402",
      "report_date": "20180314",
      "code_info": "Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019"
    }
  ]
}