{
  "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 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"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97888",
      "recalling_firm": "Otsuka ICU Medical LLC",
      "address_1": "3900 Howard Ln",
      "address_2": "",
      "postal_code": "78728-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0180-2026",
      "product_description": "POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14",
      "product_quantity": "21,696 50mL flexible containers",
      "reason_for_recall": "Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq",
      "recall_initiation_date": "20251029",
      "center_classification_date": "20251124",
      "report_date": "20251126",
      "code_info": "Lot # 1030613, Exp Date: 09/30/2026",
      "more_code_info": ""
    }
  ]
}