{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075239"
        ],
        "brand_name": [
          "LABETALOL HYDROCHLORIDE"
        ],
        "generic_name": [
          "LABETALOL HYDROCHLORIDE"
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        ],
        "product_ndc": [
          "0409-2339"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
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        "substance_name": [
          "LABETALOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "1234256"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "0409-2339-24",
          "0409-2339-34"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1GEV3BAW9J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94681",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide and Puerto Rico.",
      "recall_number": "D-0565-2024",
      "product_description": "Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC:  0409-2339-24",
      "product_quantity": "220,400 cartridges",
      "reason_for_recall": "Lack of Assurance of Sterility-The potential for incomplete crimp seals.",
      "recall_initiation_date": "20240520",
      "center_classification_date": "20240622",
      "report_date": "20240703",
      "code_info": "Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09",
      "more_code_info": ""
    }
  ]
}