{
  "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": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA211364"
        ],
        "brand_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Leading Pharma, LLC"
        ],
        "product_ndc": [
          "69315-165",
          "69315-167",
          "69315-166"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLOMIPRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "857297",
          "857301",
          "857305"
        ],
        "spl_id": [
          "48996a58-a312-4a01-ba38-0261a18bec65"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "69315-167-03",
          "69315-167-01",
          "69315-167-09",
          "69315-166-03",
          "69315-166-01",
          "69315-166-09",
          "69315-165-03",
          "69315-165-01"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0369315167014",
          "0369315167038",
          "0369315165034",
          "0369315167090"
        ],
        "unii": [
          "2LXW0L6GWJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90853",
      "recalling_firm": "Leading Pharma, LLC",
      "address_1": "3 Oak Rd",
      "address_2": "N/A",
      "postal_code": "07004-2903",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-1546-2022",
      "product_description": "ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01",
      "product_quantity": "960 bottles (100 capsules)",
      "reason_for_recall": "Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules",
      "recall_initiation_date": "20220823",
      "center_classification_date": "20220928",
      "termination_date": "20230928",
      "report_date": "20221005",
      "code_info": "Lot#: B14221, Exp. Date 02/2023"
    }
  ]
}