{
  "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": "Lexington",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020049"
        ],
        "brand_name": [
          "PENTASA"
        ],
        "generic_name": [
          "MESALAMINE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "54092-189",
          "54092-191"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MESALAMINE"
        ],
        "rxcui": [
          "206791",
          "314092",
          "476362",
          "580286"
        ],
        "spl_id": [
          "42661699-8fcc-40da-a05d-91906f9973e8"
        ],
        "spl_set_id": [
          "e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606"
        ],
        "package_ndc": [
          "54092-189-81",
          "54092-191-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0354092191123",
          "0354092189816"
        ],
        "nui": [
          "N0000175781",
          "M0000971"
        ],
        "pharm_class_epc": [
          "Aminosalicylate [EPC]"
        ],
        "pharm_class_cs": [
          "Aminosalicylic Acids [CS]"
        ],
        "unii": [
          "4Q81I59GXC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75880",
      "recalling_firm": "Shire PLC",
      "address_1": "300 Shire Way",
      "address_2": "",
      "postal_code": "02421-2101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0432-2017",
      "product_description": "Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81",
      "product_quantity": "4,520 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules",
      "recall_initiation_date": "20161202",
      "center_classification_date": "20170117",
      "termination_date": "20180601",
      "report_date": "20170125",
      "code_info": "Lot Number AE7363A, exp 06/30/2019",
      "more_code_info": ""
    }
  ]
}