{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA200656"
        ],
        "brand_name": [
          "KABIVEN"
        ],
        "generic_name": [
          "DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-712"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALANINE",
          "ARGININE",
          "ASPARTIC ACID",
          "CALCIUM CHLORIDE",
          "DEXTROSE MONOHYDRATE",
          "GLUTAMIC ACID",
          "GLYCINE",
          "HISTIDINE",
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE HYDROCHLORIDE",
          "MAGNESIUM SULFATE HEPTAHYDRATE",
          "METHIONINE",
          "PHENYLALANINE",
          "POTASSIUM CHLORIDE",
          "PROLINE",
          "SERINE",
          "SODIUM ACETATE",
          "SODIUM GLYCEROPHOSPHATE ANHYDROUS",
          "SOYBEAN OIL",
          "THREONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "VALINE"
        ],
        "spl_id": [
          "f4e7d197-8c8f-4603-ae34-cd4c204d89c3"
        ],
        "spl_set_id": [
          "afeb4837-a759-4484-a76e-e04611c459e7"
        ],
        "package_ndc": [
          "63323-712-10",
          "63323-712-15",
          "63323-712-20",
          "63323-712-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323712105",
          "0363323712204",
          "0363323712150",
          "0363323712259"
        ],
        "nui": [
          "N0000175780",
          "M0000922",
          "N0000191261",
          "M0012553"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]",
          "Lipid Emulsion [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]",
          "Lipids [CS]"
        ],
        "unii": [
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "30KYC7MIAI",
          "M4I0D6VV5M",
          "LX22YL083G",
          "3KX376GY7L",
          "TE7660XO1C",
          "4QD397987E",
          "04Y7590D77",
          "GMW67QNF9C",
          "JNJ23Q2COM",
          "SK47B8698T",
          "AE28F7PNPL",
          "47E5O17Y3R",
          "660YQ98I10",
          "9DLQ4CIU6V",
          "452VLY9402",
          "4550K0SC9B",
          "YP1H63LJ2K",
          "241ATL177A",
          "2ZD004190S",
          "8DUH1N11BX",
          "42HK56048U",
          "HG18B9YRS7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71222",
      "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": "US; Nationwide, including Puerto Rico",
      "recall_number": "D-1114-2015",
      "product_description": "KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only.  Manufactured by: FRESENIUS KABI Uppsala, Sweden.  Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.",
      "product_quantity": "5,488 Bags",
      "reason_for_recall": "Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids",
      "recall_initiation_date": "20150428",
      "center_classification_date": "20150603",
      "termination_date": "20160519",
      "report_date": "20150610",
      "code_info": "1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016."
    }
  ]
}