{
  "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,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020171"
        ],
        "brand_name": [
          "DELFLEX"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "49230-206",
          "49230-209",
          "49230-212"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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          "SODIUM CHLORIDE",
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        "package_ndc": [
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          "49230-212-52"
        ],
        "is_original_packager": [
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        "unii": [
          "LX22YL083G",
          "M4I0D6VV5M",
          "TU7HW0W0QT",
          "451W47IQ8X",
          "02F3473H9O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93690",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 920",
      "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-0218-2024",
      "product_description": "DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.",
      "product_quantity": "69,590 bags",
      "reason_for_recall": "Lack of Sterility Assurance",
      "recall_initiation_date": "20231228",
      "center_classification_date": "20240104",
      "report_date": "20240110",
      "code_info": "Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025"
    }
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}