{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018931"
        ],
        "brand_name": [
          "TRAVASOL"
        ],
        "generic_name": [
          "LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0644"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALANINE",
          "ARGININE",
          "GLYCINE",
          "HISTIDINE",
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE HYDROCHLORIDE",
          "METHIONINE",
          "PHENYLALANINE",
          "PROLINE",
          "SERINE",
          "THREONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "VALINE"
        ],
        "rxcui": [
          "801644",
          "801648"
        ],
        "spl_id": [
          "e0279078-016d-48fd-8de1-c894422b33ff"
        ],
        "spl_set_id": [
          "8543b5be-0f43-4891-9e56-d7c39fe839b5"
        ],
        "package_ndc": [
          "0338-0644-03",
          "0338-0644-04",
          "0338-0644-06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "TE7660XO1C",
          "4QD397987E",
          "04Y7590D77",
          "GMW67QNF9C",
          "JNJ23Q2COM",
          "AE28F7PNPL",
          "47E5O17Y3R",
          "9DLQ4CIU6V",
          "452VLY9402",
          "2ZD004190S",
          "8DUH1N11BX",
          "42HK56048U",
          "HG18B9YRS7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66820",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-368-2014",
      "product_description": "10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.",
      "product_quantity": "14,622 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured",
      "recall_initiation_date": "20131112",
      "center_classification_date": "20131217",
      "termination_date": "20150610",
      "report_date": "20131225",
      "code_info": "Lot: P302646, Exp 5/31/15"
    }
  ]
}