{
  "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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    }
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  "results": [
    {
      "status": "Ongoing",
      "city": "Naples",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077670"
        ],
        "brand_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "68180-352",
          "68180-353",
          "68180-978",
          "68180-986",
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        ],
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        ],
        "route": [
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        "substance_name": [
          "SERTRALINE HYDROCHLORIDE"
        ],
        "rxcui": [
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        "is_original_packager": [
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        "unii": [
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      "product_type": "Drugs",
      "event_id": "97936",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "5801 Pelican Bay Blvd",
      "address_2": "Suite 500",
      "postal_code": "34108-2755",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0227-2026",
      "product_description": "Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.",
      "product_quantity": "52,128 bottles",
      "reason_for_recall": "Defective container - seal not adhering to bottles",
      "recall_initiation_date": "20251105",
      "center_classification_date": "20251210",
      "report_date": "20251217",
      "code_info": "Lot # QB00865, exp. date Feb 2028",
      "more_code_info": ""
    }
  ]
}