{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206745"
        ],
        "brand_name": [
          "ENTECAVIR"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "68382-920",
          "68382-921"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
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        "substance_name": [
          "ENTECAVIR"
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        "rxcui": [
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          "485436"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "68382-920-16",
          "68382-920-01",
          "68382-920-30",
          "68382-920-77",
          "68382-921-06",
          "68382-921-16",
          "68382-921-01",
          "68382-921-30",
          "68382-921-77"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5968Y6H45M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97684",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0001-2026",
      "product_description": "Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.",
      "product_quantity": "912 30-count bottles",
      "reason_for_recall": "Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity",
      "recall_initiation_date": "20250924",
      "center_classification_date": "20251002",
      "report_date": "20251008",
      "code_info": "Lot#: E409308, Exp 12/31/2026"
    }
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}