{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020171"
        ],
        "brand_name": [
          "DELFLEX"
        ],
        "generic_name": [
          "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Medical Care Renal Therapies Group, LLC"
        ],
        "product_ndc": [
          "49230-206",
          "49230-209",
          "49230-212"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAPERITONEAL"
        ],
        "substance_name": [
          "CALCIUM CHLORIDE",
          "DEXTROSE MONOHYDRATE",
          "MAGNESIUM CHLORIDE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE"
        ],
        "spl_id": [
          "44506bb0-e5f3-2a05-e063-6294a90ab2c9"
        ],
        "spl_set_id": [
          "bbc5b820-4973-11e2-a192-0002a5d5c51b"
        ],
        "package_ndc": [
          "49230-206-20",
          "49230-206-30",
          "49230-206-32",
          "49230-206-50",
          "49230-206-60",
          "49230-206-62",
          "49230-206-52",
          "49230-209-23",
          "49230-209-30",
          "49230-209-32",
          "49230-209-50",
          "49230-209-60",
          "49230-209-62",
          "49230-209-52",
          "49230-212-23",
          "49230-212-30",
          "49230-212-32",
          "49230-212-50",
          "49230-212-60",
          "49230-212-62",
          "49230-212-52"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TU7HW0W0QT",
          "451W47IQ8X",
          "02F3473H9O",
          "LX22YL083G",
          "M4I0D6VV5M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79403",
      "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC",
      "address_1": "920 Winter St",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States to patients and clinics.",
      "recall_number": "D-0604-2018",
      "product_description": "DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.",
      "product_quantity": "3,734 cases",
      "reason_for_recall": "Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.",
      "recall_initiation_date": "20171220",
      "center_classification_date": "20180320",
      "termination_date": "20190214",
      "report_date": "20180328",
      "code_info": "Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019"
    }
  ]
}