{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA018449"
        ],
        "brand_name": [
          "INTRALIPID"
        ],
        "generic_name": [
          "I.V. FAT EMULSION"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0519"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SOYBEAN OIL"
        ],
        "rxcui": [
          "200317",
          "805127",
          "1799694",
          "1799696",
          "1799704",
          "1799706",
          "1799724",
          "1799725"
        ],
        "spl_id": [
          "a34dffef-567f-47fe-9f33-3370819874c8"
        ],
        "spl_set_id": [
          "a69c82da-15ba-4d4d-8d7f-871dc3981eb8"
        ],
        "package_ndc": [
          "0338-0519-58",
          "0338-0519-09",
          "0338-0519-13"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191261",
          "M0012553"
        ],
        "pharm_class_epc": [
          "Lipid Emulsion [EPC]"
        ],
        "pharm_class_cs": [
          "Lipids [CS]"
        ],
        "unii": [
          "241ATL177A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78155",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.",
      "recall_number": "D-0030-2018",
      "product_description": "Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58",
      "product_quantity": "910 bags",
      "reason_for_recall": "Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.",
      "recall_initiation_date": "20170915",
      "center_classification_date": "20171024",
      "termination_date": "20180906",
      "report_date": "20171101",
      "code_info": "Lot #: 10LE9597, Exp 04/01/19"
    }
  ]
}