{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203503"
        ],
        "brand_name": [
          "VORICONAZOLE"
        ],
        "generic_name": [
          "VORICONAZOLE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-572",
          "68462-573"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VORICONAZOLE"
        ],
        "rxcui": [
          "349434",
          "349435"
        ],
        "spl_id": [
          "1c47b796-6b3e-4321-86f6-f51fbf9a39fb"
        ],
        "spl_set_id": [
          "4cbac6ad-0faa-4181-a830-27a9f1536b7a"
        ],
        "package_ndc": [
          "68462-572-30",
          "68462-572-90",
          "68462-572-13",
          "68462-573-30",
          "68462-573-90",
          "68462-573-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462573303"
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182141",
          "N0000182140",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "unii": [
          "JFU09I87TR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96474",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0319-2025",
      "product_description": "Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20250313",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "Lot # 17231045, exp. date Apr-25"
    }
  ]
}