{
  "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-1140-2023",
      "product_description": "DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.",
      "product_quantity": "a) 44,520; b) 60,762; c) 483,912",
      "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": "a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024.   b) Lot 408790, Exp 30-Nov-2024 and   c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025"
    }
  ]
}