{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Broomfield",
      "state": "CO",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA085968"
        ],
        "brand_name": [
          "AMITRIPTYLINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "AMITRIPTYLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-1486",
          "0781-1487",
          "0781-1488",
          "0781-1489",
          "0781-1490",
          "0781-1491"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMITRIPTYLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "856762",
          "856773",
          "856783",
          "856834",
          "856845",
          "856853"
        ],
        "spl_id": [
          "9df45420-7268-454e-9624-8da48c97b7db"
        ],
        "spl_set_id": [
          "705a2bae-031d-4218-82fe-4346542c0baa"
        ],
        "package_ndc": [
          "0781-1486-10",
          "0781-1486-01",
          "0781-1486-31",
          "0781-1487-10",
          "0781-1487-01",
          "0781-1487-31",
          "0781-1488-10",
          "0781-1488-01",
          "0781-1488-31",
          "0781-1489-31",
          "0781-1489-01",
          "0781-1489-10",
          "0781-1490-10",
          "0781-1490-01",
          "0781-1490-31",
          "0781-1491-10",
          "0781-1491-01",
          "0781-1491-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "26LUD4JO9K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77567",
      "recalling_firm": "Sandoz Incorporated",
      "address_1": "2555 W Midway Blvd",
      "address_2": "N/A",
      "postal_code": "80020-1632",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States",
      "recall_number": "D-0943-2017",
      "product_description": "Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540",
      "product_quantity": "38,234 bottles",
      "reason_for_recall": "Cross Contamination With Other Product: Imipramine",
      "recall_initiation_date": "20170616",
      "center_classification_date": "20170706",
      "termination_date": "20190114",
      "report_date": "20170712",
      "code_info": "Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019."
    }
  ]
}