{
  "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": "Terminated",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA206687"
        ],
        "brand_name": [
          "SODIUM ACETATE"
        ],
        "generic_name": [
          "SODIUM ACETATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-032"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM ACETATE"
        ],
        "rxcui": [
          "312965"
        ],
        "spl_id": [
          "37c19fc5-c1ce-4ea0-9cba-4cdf32112091"
        ],
        "spl_set_id": [
          "d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b"
        ],
        "package_ndc": [
          "63323-032-04",
          "63323-032-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4550K0SC9B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89725",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0750-2022",
      "product_description": "Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047",
      "product_quantity": "118,040 vials",
      "reason_for_recall": "Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.",
      "recall_initiation_date": "20220304",
      "center_classification_date": "20220406",
      "termination_date": "20230929",
      "report_date": "20220330",
      "code_info": "Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023"
    }
  ]
}