{
  "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": [
          "ANDA214019"
        ],
        "brand_name": [
          "DAPSONE"
        ],
        "generic_name": [
          "DAPSONE"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "72578-094"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
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        "substance_name": [
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        "rxcui": [
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        "spl_id": [
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        "package_ndc": [
          "72578-094-01",
          "72578-094-02",
          "72578-094-03"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175881",
          "M0020791"
        ],
        "pharm_class_epc": [
          "Sulfone [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfones [CS]"
        ],
        "unii": [
          "8W5C518302"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95412",
      "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": "",
      "distribution_pattern": "NY",
      "recall_number": "D-0011-2025",
      "product_description": "Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.",
      "product_quantity": "2544 pumps",
      "reason_for_recall": "Crystallization",
      "recall_initiation_date": "20240924",
      "center_classification_date": "20241012",
      "report_date": "20241023",
      "code_info": "Lot #: T400512, Exp 02/28/2026",
      "more_code_info": ""
    }
  ]
}