{
  "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": "Ronkonkoma",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091239"
        ],
        "brand_name": [
          "VALUMEDS IBUPROFEN"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "SPIRIT PHARMACEUTICALS LLC"
        ],
        "product_ndc": [
          "68210-0800"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310965"
        ],
        "spl_id": [
          "28ed10e2-9113-a062-e063-6394a90a0ba3"
        ],
        "spl_set_id": [
          "a6d4ceb0-2b79-496a-aa1e-27edd507ced0"
        ],
        "package_ndc": [
          "68210-0800-1",
          "68210-0800-4"
        ],
        "is_original_packager": [
          true
        ],
        "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": [
          "WK2XYI10QM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79361",
      "recalling_firm": "Spirit Pharmaceuticals, LLC",
      "address_1": "2004 Orville Dr N Ste 2",
      "address_2": "N/A",
      "postal_code": "11779-7645",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NY",
      "recall_number": "D-0583-2018",
      "product_description": "Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1",
      "product_quantity": "144 bottles",
      "reason_for_recall": "CGMP deviations: Ibuprofen is being recalled in response to previous recall",
      "recall_initiation_date": "20180110",
      "center_classification_date": "20180309",
      "termination_date": "20210120",
      "report_date": "20180314",
      "code_info": "Lot#: HJ6138"
    }
  ]
}