{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "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": [
          "43cd31e0-97ed-1eeb-e063-6294a90a0b3d"
        ],
        "spl_set_id": [
          "c29bdfa0-4976-11e2-939b-0002a5d5c51b"
        ],
        "package_ndc": [
          "49230-206-92",
          "49230-206-94",
          "49230-206-95",
          "49230-209-92",
          "49230-209-94",
          "49230-209-95",
          "49230-212-92",
          "49230-212-94",
          "49230-212-95"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TU7HW0W0QT",
          "451W47IQ8X",
          "M4I0D6VV5M",
          "02F3473H9O",
          "LX22YL083G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87907",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0608-2021",
      "product_description": "DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL  (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,",
      "product_quantity": "39 cases",
      "reason_for_recall": "Temperature Abuse: Product exposed to temperature outside specified limits.",
      "recall_initiation_date": "20210428",
      "center_classification_date": "20210609",
      "termination_date": "20210917",
      "report_date": "20210616",
      "code_info": "Lot #: a) 20PU02010, Exp. date June 2022 and b) 20SU04033, Exp. date July 2022"
    }
  ]
}