{
  "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": "Completed",
      "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": "91883",
      "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-0542-2023",
      "product_description": "Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.",
      "product_quantity": "a) 95,448 bags; b) 174,522 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.",
      "recall_initiation_date": "20230315",
      "center_classification_date": "20230424",
      "report_date": "20230503",
      "code_info": "Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024"
    }
  ]
}