{
  "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": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214585"
        ],
        "brand_name": [
          "MESALAMINE"
        ],
        "generic_name": [
          "MESALAMINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries Inc."
        ],
        "product_ndc": [
          "63304-089"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MESALAMINE"
        ],
        "rxcui": [
          "476362"
        ],
        "spl_id": [
          "d41a599a-71be-4294-9b53-d1cbefe905d5"
        ],
        "spl_set_id": [
          "c2f84490-70b8-4998-907d-a77e9f791de1"
        ],
        "package_ndc": [
          "63304-089-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363304089134"
        ],
        "nui": [
          "N0000175781",
          "M0000971"
        ],
        "pharm_class_epc": [
          "Aminosalicylate [EPC]"
        ],
        "pharm_class_cs": [
          "Aminosalicylic Acids [CS]"
        ],
        "unii": [
          "4Q81I59GXC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93909",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-0350-2024",
      "product_description": "Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.",
      "product_quantity": "54,960 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out of specification for dissolution.",
      "recall_initiation_date": "20240205",
      "center_classification_date": "20240223",
      "report_date": "20240306",
      "code_info": "Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.",
      "more_code_info": ""
    }
  ]
}