{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207310"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "65219-466",
          "65219-468",
          "65219-470",
          "65219-472",
          "65219-474"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807631",
          "1807632",
          "1807633",
          "1807634",
          "1807639"
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        "spl_id": [
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        "spl_set_id": [
          "037ac04d-f8f3-4bb8-993a-ac8f7683ff83"
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        "package_ndc": [
          "65219-466-05",
          "65219-466-60",
          "65219-468-05",
          "65219-468-50",
          "65219-470-05",
          "65219-470-30",
          "65219-472-05",
          "65219-472-20",
          "65219-474-05",
          "65219-474-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
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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-0427-2026",
      "product_description": "0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC (\"Fresenius Kabi\"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260311",
      "center_classification_date": "20260403",
      "report_date": "20260415",
      "code_info": "Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.",
      "more_code_info": ""
    }
  ]
}