{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA017512"
        ],
        "brand_name": [
          "DIANEAL LOW CALCIUM WITH DEXTROSE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE"
        ],
        "manufacturer_name": [
          "Vantive US Healthcare LLC"
        ],
        "product_ndc": [
          "0941-0409",
          "0941-0411",
          "0941-0413",
          "0941-0415",
          "0941-0457",
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          "0941-0433",
          "0941-0484",
          "0941-0487",
          "0941-0490"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAPERITONEAL"
        ],
        "substance_name": [
          "CALCIUM CHLORIDE",
          "DEXTROSE MONOHYDRATE",
          "MAGNESIUM CHLORIDE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE"
        ],
        "rxcui": [
          "799999",
          "800003",
          "800057",
          "800061",
          "800062",
          "800064",
          "800066",
          "800074",
          "800111",
          "800115",
          "800472",
          "800474"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0941-0411-05",
          "0941-0411-06",
          "0941-0411-07",
          "0941-0411-04",
          "0941-0411-11",
          "0941-0413-05",
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        ],
        "is_original_packager": [
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        "unii": [
          "TU7HW0W0QT",
          "451W47IQ8X",
          "02F3473H9O",
          "LX22YL083G",
          "M4I0D6VV5M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65784",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-831-2013",
      "product_description": "DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product L5B4826, NDC 0941-0409-07",
      "product_quantity": "39,486 containers",
      "reason_for_recall": "Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.",
      "recall_initiation_date": "20130724",
      "center_classification_date": "20130801",
      "termination_date": "20140624",
      "report_date": "20130807",
      "code_info": "Product Code: L5B4826, Lot #: C886820, Exp 11/14",
      "more_code_info": ""
    }
  ]
}