{
  "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": "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"
        ],
        "substance_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "857297",
          "857301",
          "857305"
        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "68180-492-01",
          "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": [
          true
        ],
        "upc": [
          "0368180494065",
          "0368180493068"
        ],
        "unii": [
          "2LXW0L6GWJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96681",
      "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": "USA nationwide",
      "recall_number": "D-0377-2025",
      "product_description": "clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01",
      "product_quantity": "2724 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.",
      "recall_initiation_date": "20250410",
      "center_classification_date": "20250418",
      "termination_date": "20260105",
      "report_date": "20250430",
      "code_info": "Lot #: M300442, Exp Date: 6/30/2025"
    }
  ]
}