{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207449"
        ],
        "brand_name": [
          "DEXTROSE"
        ],
        "generic_name": [
          "DEXTROSE MONOHYDRATE"
        ],
        "manufacturer_name": [
          "FRESENIUS KABI USA, LLC"
        ],
        "product_ndc": [
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          "65219-464",
          "65219-458",
          "65219-460",
          "65219-462"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXTROSE MONOHYDRATE"
        ],
        "rxcui": [
          "1795607",
          "1795609",
          "1795610",
          "1795612",
          "1795616"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "65219-456-05",
          "65219-456-60",
          "65219-464-05",
          "65219-464-50",
          "65219-458-05",
          "65219-458-30",
          "65219-460-05",
          "65219-460-20",
          "65219-462-05",
          "65219-462-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G"
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      },
      "product_type": "Drugs",
      "event_id": "98581",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide , Alaska, and Puerto Rico.",
      "recall_number": "D-0435-2026",
      "product_description": "5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC (\"Fresenius Kabi\"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260311",
      "center_classification_date": "20260403",
      "report_date": "20260415",
      "code_info": "Batch# 6402296, Exp Date: 07/31/2026.",
      "more_code_info": ""
    }
  ]
}