{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA091276"
        ],
        "brand_name": [
          "INDOMETHACIN"
        ],
        "generic_name": [
          "INDOMETHACIN"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-302",
          "68462-406"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "INDOMETHACIN"
        ],
        "rxcui": [
          "197817",
          "197818"
        ],
        "spl_id": [
          "bcf62935-0bd5-479f-9680-c5b4eba5a529"
        ],
        "spl_set_id": [
          "f7ed39e2-5431-4e47-935c-c7441d058f94"
        ],
        "package_ndc": [
          "68462-406-01",
          "68462-406-10",
          "68462-302-01",
          "68462-302-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462406014",
          "0368462302019"
        ],
        "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": "79570",
      "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": "Letter",
      "distribution_pattern": "Nationwide in the United States.",
      "recall_number": "D-0606-2018",
      "product_description": "Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ  07430, NDC 68462-302-01.",
      "product_quantity": "109,080 Bottles",
      "reason_for_recall": "Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of \"One or two capsules 2 or 3 times a day.\" rather than the correct usual adult dosage of \"One capsule 2 or 3 times a day.",
      "recall_initiation_date": "20180319",
      "center_classification_date": "20180326",
      "termination_date": "20191216",
      "report_date": "20180404",
      "code_info": "Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.",
      "more_code_info": ""
    }
  ]
}