{
  "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": "Newtown",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079175"
        ],
        "brand_name": [
          "INDOMETHACIN"
        ],
        "generic_name": [
          "INDOMETHACIN"
        ],
        "manufacturer_name": [
          "KVK-Tech, Inc."
        ],
        "product_ndc": [
          "10702-016"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
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        "rxcui": [
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        "spl_id": [
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          "10702-016-06",
          "10702-016-09",
          "10702-016-01",
          "10702-016-50",
          "10702-016-10"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0310702016101",
          "0310702016033"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
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        "unii": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "96847",
      "recalling_firm": "KVK Tech, Inc.",
      "address_1": "110 Terry Dr",
      "address_2": "N/A",
      "postal_code": "18940-3427",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0445-2025",
      "product_description": "Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.",
      "product_quantity": "9107 bottles",
      "reason_for_recall": "cGMP deviations",
      "recall_initiation_date": "20250509",
      "center_classification_date": "20250521",
      "report_date": "20250528",
      "code_info": "Lot#: 18400A, Exp 7/31/2027"
    }
  ]
}