{
  "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": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "72578-102"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
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        "rxcui": [
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        ],
        "package_ndc": [
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        ],
        "is_original_packager": [
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        ],
        "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": "97424",
      "recalling_firm": "VIONA PHARMACEUTICALS INC",
      "address_1": "20 Commerce Dr Ste 340",
      "address_2": "N/A",
      "postal_code": "07016-3617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0595-2025",
      "product_description": "Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India.  Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.  NDC:  72578-102-04",
      "product_quantity": "3960  bottles",
      "reason_for_recall": "Discoloration",
      "recall_initiation_date": "20250812",
      "center_classification_date": "20250821",
      "report_date": "20250827",
      "code_info": "Lot #: T401968"
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  ]
}