{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203501"
        ],
        "brand_name": [
          "INDOMETHACIN"
        ],
        "generic_name": [
          "INDOMETHACIN"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-325"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "INDOMETHACIN"
        ],
        "rxcui": [
          "310992"
        ],
        "spl_id": [
          "e729f88c-b2c8-4462-98be-7184de95b01d"
        ],
        "spl_set_id": [
          "532d40b2-c05c-4d4f-b7ee-e6434c4c27fc"
        ],
        "package_ndc": [
          "68462-325-60",
          "68462-325-90",
          "68462-325-01",
          "68462-325-05",
          "68462-325-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462325605"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "XXE1CET956"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95075",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0643-2024",
      "product_description": "Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle  (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.",
      "product_quantity": "2404 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: below specification results",
      "recall_initiation_date": "20240731",
      "center_classification_date": "20240823",
      "report_date": "20240904",
      "code_info": "Lot#: 17240105, Exp 12/31/2025",
      "more_code_info": ""
    }
  ]
}