{
  "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": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212730"
        ],
        "brand_name": [
          "PIRFENIDONE"
        ],
        "generic_name": [
          "PIRFENIDONE"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-467",
          "16729-468"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PIRFENIDONE"
        ],
        "rxcui": [
          "1868014",
          "1868018"
        ],
        "spl_id": [
          "462905a9-67d0-513b-e063-6294a90aa9b4"
        ],
        "spl_set_id": [
          "fab59395-1c5d-4c64-ba47-34d75736e983"
        ],
        "package_ndc": [
          "16729-468-15",
          "16729-468-64",
          "16729-467-15",
          "16729-467-85",
          "16729-467-64"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191420",
          "M0018236"
        ],
        "pharm_class_epc": [
          "Pyridone [EPC]"
        ],
        "pharm_class_cs": [
          "Pyridones [CS]"
        ],
        "unii": [
          "D7NLD2JX7U"
        ],
        "upc": [
          "316729467155",
          "316729467858"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0419-2023",
      "product_description": "Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.",
      "product_quantity": "2614 cartons",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches: P2202518, P2202512, Exp. Date 4/30/2024,  P2204588, P2204589, Exp. Date 7/31/2024",
      "more_code_info": ""
    }
  ]
}