{
  "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": [
          "ANDA076766"
        ],
        "brand_name": [
          "FLUCONAZOLE"
        ],
        "generic_name": [
          "FLUCONAZOLE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-6045",
          "0338-6046"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FLUCONAZOLE"
        ],
        "rxcui": [
          "1721314",
          "1721315"
        ],
        "spl_id": [
          "cd799cf9-3fc9-431e-a1a3-e5fc7fe57544"
        ],
        "spl_set_id": [
          "cd24a261-9c15-42b4-8040-89d2dbda174e"
        ],
        "package_ndc": [
          "0338-6046-48",
          "0338-6045-37"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182140",
          "N0000182141",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "unii": [
          "8VZV102JFY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70057",
      "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, United Arab Emirates, and Columbia",
      "recall_number": "D-0380-2015",
      "product_description": "Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA, NDC 0338-6046-48, Product Code 2J1446.",
      "product_quantity": "31,130 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.",
      "recall_initiation_date": "20141223",
      "center_classification_date": "20150126",
      "termination_date": "20160421",
      "report_date": "20150204",
      "code_info": "Lot #: P318394; Exp 05/31/16"
    }
  ]
}