{
  "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": "Livonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203437"
        ],
        "brand_name": [
          "ENTACAPONE"
        ],
        "generic_name": [
          "ENTACAPONE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6822"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENTACAPONE"
        ],
        "rxcui": [
          "317094"
        ],
        "spl_id": [
          "3e89aac1-4b38-41fd-bbd7-af716570f424"
        ],
        "spl_set_id": [
          "863025af-2b71-477d-baa9-3ce7f435e385"
        ],
        "package_ndc": [
          "0904-6822-04",
          "0904-6822-07"
        ],
        "original_packager_product_ndc": [
          "65862-654"
        ],
        "nui": [
          "N0000175756",
          "N0000175757"
        ],
        "pharm_class_moa": [
          "Catechol O-Methyltransferase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Catechol-O-Methyltransferase Inhibitor [EPC]"
        ],
        "unii": [
          "4975G9NM6T"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88638",
      "recalling_firm": "The Harvard Drug Group",
      "address_1": "17187 N Laurel Park Dr Ste 300",
      "address_2": "",
      "postal_code": "48152-2600",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "CO, FL, MO, OH",
      "recall_number": "D-0806-2021",
      "product_description": "Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.  NDC 0904-6822-04",
      "product_quantity": "1,632 cartons",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20210729",
      "center_classification_date": "20210917",
      "termination_date": "20230219",
      "report_date": "20210929",
      "code_info": "Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022",
      "more_code_info": ""
    }
  ]
}