{
  "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": "Ongoing",
      "city": "Lake Forest",
      "state": "IL",
      "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": [
          "1807548",
          "1807549",
          "1807550",
          "1807551",
          "1807552",
          "1807627",
          "1807630",
          "1807631",
          "1807632",
          "1807633",
          "1807634",
          "1807639"
        ],
        "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",
          "0990-7984-20",
          "0990-7984-13",
          "0990-7984-23",
          "0990-7984-36",
          "0990-7985-02",
          "0990-7985-03",
          "0990-7985-09"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91113",
      "recalling_firm": "ICU Medical Inc",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0062-2023",
      "product_description": "0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37",
      "product_quantity": "137,120 bags",
      "reason_for_recall": "Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.",
      "recall_initiation_date": "20221109",
      "center_classification_date": "20221116",
      "report_date": "20221123",
      "code_info": "Lot: 5829936, Exp. MAR 31 2024"
    }
  ]
}