{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205209"
        ],
        "brand_name": [
          "DARIFENACIN"
        ],
        "generic_name": [
          "DARIFENACIN"
        ],
        "manufacturer_name": [
          "Torrent Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "13668-202",
          "13668-203"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DARIFENACIN HYDROBROMIDE"
        ],
        "rxcui": [
          "485421",
          "485423"
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        "spl_id": [
          "fe809224-0deb-4a82-b454-054be6dd4931"
        ],
        "spl_set_id": [
          "e84f1ae3-b9a2-4a15-a299-c75373891cc1"
        ],
        "package_ndc": [
          "13668-202-30",
          "13668-202-90",
          "13668-202-05",
          "13668-203-30",
          "13668-203-05",
          "13668-203-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0313668202304",
          "0313668203301"
        ],
        "unii": [
          "CR02EYQ8GV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0584-2021",
      "product_description": "Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only,  Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30",
      "product_quantity": "37 bottles",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "BDZ9G005"
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  ]
}