{
  "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": "Ongoing",
      "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": "94846",
      "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": "US Nationwide, Canada",
      "recall_number": "D-0587-2024",
      "product_description": "Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.  NDC:  0941-0457-01",
      "product_quantity": "6,874 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.",
      "recall_initiation_date": "20240617",
      "center_classification_date": "20240706",
      "report_date": "20240717",
      "code_info": "Lot R24B25FA; Exp. 2/28/2026"
    }
  ]
}