{
  "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": "Cranford",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212294"
        ],
        "brand_name": [
          "TAVABOROLE"
        ],
        "generic_name": [
          "TAVABOROLE"
        ],
        "manufacturer_name": [
          "Viona Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "72578-102"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TAVABOROLE"
        ],
        "rxcui": [
          "1543177"
        ],
        "spl_id": [
          "266f7bbc-b540-4681-8144-cbb823f34f0e"
        ],
        "spl_set_id": [
          "c13610c8-c57a-4519-b37d-eb4fbdcec398"
        ],
        "package_ndc": [
          "72578-102-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191279",
          "N0000000150",
          "M0002832"
        ],
        "pharm_class_epc": [
          "Oxaborole Antifungal [EPC]"
        ],
        "pharm_class_moa": [
          "Protein Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Boron Compounds [CS]"
        ],
        "unii": [
          "K124A4EUQ3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97756",
      "recalling_firm": "VIONA PHARMACEUTICALS INC",
      "address_1": "20 Commerce Dr Ste 340",
      "address_2": "",
      "postal_code": "07016-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0016-2026",
      "product_description": "Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.",
      "product_quantity": "13080 bottles",
      "reason_for_recall": "Discoloration",
      "recall_initiation_date": "20251006",
      "center_classification_date": "20251010",
      "report_date": "20251022",
      "code_info": "Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26",
      "more_code_info": ""
    }
  ]
}