{
  "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": [
          "ANDA075880"
        ],
        "brand_name": [
          "PREMASOL - SULFITE-FREE (AMINO ACID)"
        ],
        "generic_name": [
          "LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-1130",
          "0338-1131"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ALANINE",
          "ARGININE",
          "ASPARTIC ACID",
          "CYSTEINE HYDROCHLORIDE",
          "GLUTAMIC ACID",
          "GLYCINE",
          "HISTIDINE",
          "ISOLEUCINE",
          "LEUCINE",
          "LYSINE ACETATE",
          "METHIONINE",
          "PHENYLALANINE",
          "PROLINE",
          "SERINE",
          "TAURINE",
          "THREONINE",
          "TRYPTOPHAN",
          "TYROSINE",
          "VALINE"
        ],
        "rxcui": [
          "801395",
          "801398",
          "801403",
          "801405"
        ],
        "spl_id": [
          "4083b5c8-ad5f-43f6-ab19-3c87acb2883f"
        ],
        "spl_set_id": [
          "9afdcc3e-0d06-47f4-86ca-40da48b2b02b"
        ],
        "package_ndc": [
          "0338-1130-03",
          "0338-1130-04",
          "0338-1130-06",
          "0338-1131-03"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175780",
          "M0000922"
        ],
        "pharm_class_epc": [
          "Amino Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids [CS]"
        ],
        "unii": [
          "OF5P57N2ZX",
          "94ZLA3W45F",
          "30KYC7MIAI",
          "ZT934N0X4W",
          "3KX376GY7L",
          "TE7660XO1C",
          "4QD397987E",
          "04Y7590D77",
          "GMW67QNF9C",
          "TTL6G7LIWZ",
          "AE28F7PNPL",
          "47E5O17Y3R",
          "9DLQ4CIU6V",
          "452VLY9402",
          "1EQV5MLY3D",
          "2ZD004190S",
          "8DUH1N11BX",
          "42HK56048U",
          "HG18B9YRS7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75835",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US",
      "recall_number": "D-0425-2017",
      "product_description": "10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only,  Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06",
      "product_quantity": "3,528 eaches",
      "reason_for_recall": "Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.",
      "recall_initiation_date": "20161206",
      "center_classification_date": "20170109",
      "termination_date": "20180326",
      "report_date": "20170118",
      "code_info": "Lot #:  P333617, Exp 4/30/17",
      "more_code_info": ""
    }
  ]
}