{
  "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": {
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  "results": [
    {
      "status": "Ongoing",
      "city": "Cranford",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214019"
        ],
        "brand_name": [
          "DAPSONE"
        ],
        "generic_name": [
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        "manufacturer_name": [
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        "product_ndc": [
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        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        "substance_name": [
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          "72578-094-02",
          "72578-094-03"
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        "is_original_packager": [
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        ],
        "nui": [
          "N0000175881",
          "M0020791"
        ],
        "pharm_class_epc": [
          "Sulfone [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfones [CS]"
        ],
        "unii": [
          "8W5C518302"
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      },
      "product_type": "Drugs",
      "event_id": "95930",
      "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": "US Nationwide",
      "recall_number": "D-0171-2025",
      "product_description": "Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.  packaged in an Airless pump pack",
      "product_quantity": "23304 packs",
      "reason_for_recall": "Crystallization",
      "recall_initiation_date": "20241210",
      "center_classification_date": "20250102",
      "report_date": "20250108",
      "code_info": "Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.",
      "more_code_info": ""
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}