{
  "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": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA020161"
        ],
        "brand_name": [
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "ICU Medical Inc."
        ],
        "product_ndc": [
          "0990-7074",
          "0990-7075",
          "0990-7077"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "312507",
          "1860239",
          "1860241",
          "1860463",
          "1860466"
        ],
        "spl_id": [
          "e76c9e23-41f3-4d57-a5bf-684417a53e5e"
        ],
        "spl_set_id": [
          "eb56a807-ea94-4edb-9811-a04b19568468"
        ],
        "package_ndc": [
          "0990-7074-26",
          "0990-7075-14",
          "0990-7075-26",
          "0990-7077-14",
          "0990-7077-26",
          "0030990707"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96250",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "600 N Field Dr",
      "address_2": "",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0268-2025",
      "product_description": "POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269",
      "product_quantity": "unknown",
      "reason_for_recall": "Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq",
      "recall_initiation_date": "20250213",
      "center_classification_date": "20250310",
      "report_date": "20250319",
      "code_info": "Lot 1023172, Exp Date: 31 January 2026",
      "more_code_info": ""
    }
  ]
}