{
  "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 I",
      "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": "73118",
      "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 Puerto Rico",
      "recall_number": "D-0864-2016",
      "product_description": "CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B7721, NDC 0338-1123-04.",
      "product_quantity": "7,436 bags",
      "reason_for_recall": "Presence of Particulate Matter: identified as dried skin.",
      "recall_initiation_date": "20160121",
      "center_classification_date": "20160523",
      "termination_date": "20180226",
      "report_date": "20160601",
      "code_info": "Lot #: P333930, Exp 05/31/2017"
    }
  ]
}