{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Naples",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209294"
        ],
        "brand_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CLOMIPRAMINE HYDROCHLORIDE CAPSULES"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-492",
          "68180-493",
          "68180-494"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
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        "substance_name": [
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        "rxcui": [
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          "857301",
          "857305"
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        "package_ndc": [
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          "68180-492-07",
          "68180-492-09",
          "68180-492-06",
          "68180-493-01",
          "68180-493-07",
          "68180-493-09",
          "68180-493-06",
          "68180-494-01",
          "68180-494-07",
          "68180-494-09",
          "68180-494-06"
        ],
        "is_original_packager": [
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        "upc": [
          "0368180494065",
          "0368180493068"
        ],
        "unii": [
          "2LXW0L6GWJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97159",
      "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-0537-2025",
      "product_description": "clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01",
      "product_quantity": "2,724 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.",
      "recall_initiation_date": "20250627",
      "center_classification_date": "20250721",
      "termination_date": "20260105",
      "report_date": "20250730",
      "code_info": "Lot # M300464, exp. date June, 2025"
    }
  ]
}