{
  "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,
      "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",
          "0941-0459",
          "0941-0426",
          "0941-0427",
          "0941-0429",
          "0941-0424",
          "0941-0430",
          "0941-0433",
          "0941-0484",
          "0941-0487",
          "0941-0490"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAPERITONEAL"
        ],
        "substance_name": [
          "DEXTROSE MONOHYDRATE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE",
          "CALCIUM CHLORIDE",
          "MAGNESIUM CHLORIDE"
        ],
        "rxcui": [
          "799999",
          "800003",
          "800057",
          "800061",
          "800062",
          "800064",
          "800066",
          "800074",
          "800111",
          "800115",
          "800472",
          "800474"
        ],
        "spl_id": [
          "194f41a6-655b-456a-955f-7566eb429b7b"
        ],
        "spl_set_id": [
          "aa268d3f-7389-4f25-801f-5d4825495f08"
        ],
        "package_ndc": [
          "0941-0411-05",
          "0941-0411-06",
          "0941-0411-07",
          "0941-0411-04",
          "0941-0411-11",
          "0941-0413-05",
          "0941-0413-06",
          "0941-0413-07",
          "0941-0413-01",
          "0941-0413-04",
          "0941-0415-05",
          "0941-0415-06",
          "0941-0415-04",
          "0941-0415-07",
          "0941-0415-01",
          "0941-0409-06",
          "0941-0409-05",
          "0941-0409-07",
          "0941-0409-01",
          "0941-0457-08",
          "0941-0457-02",
          "0941-0457-05",
          "0941-0457-01",
          "0941-0459-08",
          "0941-0459-02",
          "0941-0459-05",
          "0941-0459-01",
          "0941-0426-52",
          "0941-0426-53",
          "0941-0427-52",
          "0941-0427-53",
          "0941-0429-52",
          "0941-0429-53",
          "0941-0424-51",
          "0941-0424-52",
          "0941-0424-53",
          "0941-0430-51",
          "0941-0430-52",
          "0941-0430-53",
          "0941-0433-51",
          "0941-0433-52",
          "0941-0433-53",
          "0941-0484-01",
          "0941-0487-01",
          "0941-0490-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G",
          "M4I0D6VV5M",
          "TU7HW0W0QT",
          "451W47IQ8X",
          "02F3473H9O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92931",
      "recalling_firm": "Baxter Healthcare Corporation",
      "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 in the USA",
      "recall_number": "D-1141-2023",
      "product_description": "Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07",
      "product_quantity": "22,112 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.",
      "recall_initiation_date": "20230811",
      "center_classification_date": "20230829",
      "termination_date": "20240716",
      "report_date": "20230906",
      "code_info": "Lot Y406734, Exp 31-Oct-2024"
    }
  ]
}