{
  "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": "Farmingdale",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075010"
        ],
        "brand_name": [
          "IBUPROFEN"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "Discount Drug Mart"
        ],
        "product_ndc": [
          "53943-291"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "310965"
        ],
        "spl_id": [
          "0dae6ecd-d845-4a67-a404-58674da7114d"
        ],
        "spl_set_id": [
          "cffad7af-44f5-4e54-9e46-c3c5d4ca182f"
        ],
        "package_ndc": [
          "53943-291-15",
          "53943-291-12",
          "53943-291-14"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0093351027697"
        ],
        "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": "79349",
      "recalling_firm": "Time-Cap Laboratories, Inc.",
      "address_1": "7 Michael Ave",
      "address_2": "N/A",
      "postal_code": "11735-3921",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0686-2018",
      "product_description": "Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.",
      "recall_initiation_date": "20180111",
      "center_classification_date": "20180422",
      "termination_date": "20210120",
      "report_date": "20180502",
      "code_info": "a) D167C, exp 2/18, E135C, exp 3/18;  b) D172C, exp 2/18;   c) D167C, exp 2/18, E135C, exp 3/18"
    }
  ]
}