{
  "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": "Ongoing",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018090"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "ICU Medical Inc."
        ],
        "product_ndc": [
          "0990-7730",
          "0990-7983",
          "0990-7984",
          "0990-7985"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
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          "1807549",
          "1807550",
          "1807551",
          "1807552",
          "1807627",
          "1807630",
          "1807631",
          "1807632",
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          "1807634",
          "1807639"
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        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0990-7730-36",
          "0990-7730-37",
          "0990-7983-61",
          "0990-7983-02",
          "0990-7983-03",
          "0990-7983-09",
          "0990-7983-55",
          "0990-7983-53",
          "0990-7984-37",
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          "0990-7984-13",
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          "0990-7985-02",
          "0990-7985-03",
          "0990-7985-09"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97841",
      "recalling_firm": "Otsuka ICU Medical LLC",
      "address_1": "3900 Howard Ln",
      "address_2": "N/A",
      "postal_code": "78728-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA.",
      "recall_number": "D-0143-2026",
      "product_description": "0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37",
      "product_quantity": "509,360 100 mL bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Potential for flexible container leaks.",
      "recall_initiation_date": "20251027",
      "center_classification_date": "20251030",
      "report_date": "20251105",
      "code_info": "Lot # 1029921, Exp Date: 28 February 2027"
    }
  ]
}