{
  "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": [
          "ANDA090796"
        ],
        "brand_name": [
          "IBUPROFEN"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "TIME CAP LABORATORIES, INC"
        ],
        "product_ndc": [
          "49483-602",
          "49483-603",
          "49483-604"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "197805",
          "197806",
          "197807"
        ],
        "spl_id": [
          "27b8b074-c62d-7214-e063-6294a90adb69"
        ],
        "spl_set_id": [
          "ec3e8443-d742-4c25-8516-f0df4ebfccdc"
        ],
        "package_ndc": [
          "49483-602-01",
          "49483-602-50",
          "49483-603-03",
          "49483-603-50",
          "49483-603-05",
          "49483-603-01",
          "49483-604-01",
          "49483-604-50",
          "49483-604-05",
          "49483-604-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349483604504",
          "0349483604016",
          "0349483602012",
          "0349483602500",
          "0349483603507",
          "0349483603019"
        ],
        "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-0687-2018",
      "product_description": "Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India",
      "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) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18    b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18,"
    }
  ]
}