{
  "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": "69868",
      "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-0301-2015",
      "product_description": "Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04",
      "product_quantity": "7,220 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal",
      "recall_initiation_date": "20141125",
      "center_classification_date": "20141216",
      "termination_date": "20151028",
      "report_date": "20141224",
      "code_info": "Product Code 2B7717 Lot # P311357, exp 12/31/2015"
    }
  ]
}