{
  "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": [
          "NDA020849"
        ],
        "brand_name": [
          "PROSOL"
        ],
        "generic_name": [
          "VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0499"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALANINE",
          "ARGININE",
          "ASPARTIC ACID",
          "GLUTAMIC ACID",
          "GLYCINE",
          "HISTIDINE",
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE ACETATE",
          "METHIONINE",
          "PHENYLALANINE",
          "PROLINE",
          "SERINE",
          "THREONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "VALINE"
        ],
        "rxcui": [
          "801133",
          "801136"
        ],
        "spl_id": [
          "ee240b46-c2a9-42e0-8750-a5a554becea3"
        ],
        "spl_set_id": [
          "cc2ace81-5881-43f1-ba94-41b674adc2fc"
        ],
        "package_ndc": [
          "0338-0499-06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "30KYC7MIAI",
          "3KX376GY7L",
          "TE7660XO1C",
          "4QD397987E",
          "04Y7590D77",
          "GMW67QNF9C",
          "TTL6G7LIWZ",
          "AE28F7PNPL",
          "47E5O17Y3R",
          "9DLQ4CIU6V",
          "452VLY9402",
          "2ZD004190S",
          "8DUH1N11BX",
          "42HK56048U",
          "HG18B9YRS7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68963",
      "recalling_firm": "Baxter Healthcare Corp",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1542-2014",
      "product_description": "ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL  60015 USA, Product Code 2B6186, NDC 0338-0499-06.",
      "product_quantity": "6,204 bags",
      "reason_for_recall": "Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).",
      "recall_initiation_date": "20140804",
      "center_classification_date": "20140818",
      "termination_date": "20150610",
      "report_date": "20140827",
      "code_info": "Lot #: P306225, Exp 08/14",
      "more_code_info": ""
    }
  ]
}