{
  "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": [
          "NDA020678"
        ],
        "brand_name": [
          "CLINIMIX E"
        ],
        "generic_name": [
          "LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-0202",
          "0338-1142",
          "0338-1144",
          "0338-1113",
          "0338-1145",
          "0338-1115",
          "0338-1147",
          "0338-1123",
          "0338-1125",
          "0338-1148",
          "0338-0206",
          "0338-0210",
          "0338-0214",
          "0338-7020",
          "0338-7022",
          "0338-7024",
          "0338-7026",
          "0338-7028",
          "0338-7030",
          "0338-7032",
          "0338-7034",
          "0338-7036"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALANINE",
          "ARGININE",
          "CALCIUM CHLORIDE",
          "DEXTROSE",
          "GLYCINE",
          "HISTIDINE",
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE",
          "MAGNESIUM CHLORIDE",
          "METHIONINE",
          "PHENYLALANINE",
          "POTASSIUM PHOSPHATE, DIBASIC",
          "PROLINE",
          "SERINE",
          "SODIUM CHLORIDE",
          "THREONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "VALINE"
        ],
        "rxcui": [
          "800998",
          "801000",
          "801010",
          "801012",
          "801019",
          "801021",
          "801029",
          "801031",
          "1090635",
          "1090639"
        ],
        "spl_id": [
          "dc7ce216-a4a9-41cf-80e3-5e901b8cecdf"
        ],
        "spl_set_id": [
          "8469d6fb-d6ef-476f-8cc3-0905192de0a8"
        ],
        "package_ndc": [
          "0338-1142-03",
          "0338-1144-03",
          "0338-1113-04",
          "0338-1145-03",
          "0338-1115-04",
          "0338-1147-03",
          "0338-1123-04",
          "0338-1125-04",
          "0338-1148-03",
          "0338-0202-01",
          "0338-0202-06",
          "0338-0206-01",
          "0338-0206-04",
          "0338-0210-01",
          "0338-0210-06",
          "0338-0214-01",
          "0338-0214-04",
          "0338-7020-01",
          "0338-7020-06",
          "0338-7022-01",
          "0338-7022-06",
          "0338-7024-01",
          "0338-7024-04",
          "0338-7026-01",
          "0338-7026-06",
          "0338-7028-01",
          "0338-7028-04",
          "0338-7030-01",
          "0338-7030-06",
          "0338-7032-01",
          "0338-7032-04",
          "0338-7034-01",
          "0338-7034-06",
          "0338-7036-01",
          "0338-7036-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "TE7660XO1C",
          "OF5P57N2ZX",
          "M4I0D6VV5M",
          "04Y7590D77",
          "452VLY9402",
          "HG18B9YRS7",
          "94ZLA3W45F",
          "451W47IQ8X",
          "IY9XDZ35W2",
          "4QD397987E",
          "4550K0SC9B",
          "GMW67QNF9C",
          "47E5O17Y3R",
          "CI71S98N1Z",
          "02F3473H9O",
          "K3Z4F929H6",
          "8DUH1N11BX",
          "AE28F7PNPL",
          "9DLQ4CIU6V",
          "2ZD004190S",
          "42HK56048U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70695",
      "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 and Singapore",
      "recall_number": "D-0428-2015",
      "product_description": "Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04",
      "product_quantity": "7444 containers",
      "reason_for_recall": "Lack of Assurance of Sterility; increased complaints received for leaks",
      "recall_initiation_date": "20150323",
      "center_classification_date": "20150331",
      "termination_date": "20161020",
      "report_date": "20150408",
      "code_info": "Product code: 2B7722; Lot#: P306365, exp date: 8/31/2015"
    }
  ]
}