{
  "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": "2026-03-18",
    "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": [
          "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": [
          "1fe7ab39-a56f-48bb-97fe-71eb295870a6"
        ],
        "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",
          "TU7HW0W0QT",
          "02F3473H9O",
          "451W47IQ8X",
          "M4I0D6VV5M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81881",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.",
      "recall_number": "D-0351-2019",
      "product_description": "Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL  60015; Product Code 5B9766, NDC 0941-0424-52.",
      "product_quantity": "29,370 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.",
      "recall_initiation_date": "20190102",
      "center_classification_date": "20190108",
      "termination_date": "20200429",
      "report_date": "20190116",
      "code_info": "Lot #: Y281477, Expiry: 02/2020",
      "more_code_info": ""
    }
  ]
}