{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079175"
        ],
        "brand_name": [
          "INDOMETHACIN"
        ],
        "generic_name": [
          "INDOMETHACIN"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-411"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "INDOMETHACIN"
        ],
        "rxcui": [
          "310992"
        ],
        "spl_id": [
          "423d8198-e51f-90c2-e063-6294a90a1de7"
        ],
        "spl_set_id": [
          "5a65b650-ea9b-4d0d-b62f-5971df1e62b4"
        ],
        "package_ndc": [
          "68084-411-11",
          "68084-411-21"
        ],
        "original_packager_product_ndc": [
          "10702-016"
        ],
        "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": "96898",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0454-2025",
      "product_description": "Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).",
      "product_quantity": "21 cartons",
      "reason_for_recall": "cGMP deviations",
      "recall_initiation_date": "20250515",
      "center_classification_date": "20250602",
      "report_date": "20250611",
      "code_info": "Lot #: 1021950, Exp. 11/30/2026"
    }
  ]
}