{
  "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": "77576",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide U.S.A.",
      "recall_number": "D-1055-2017",
      "product_description": "Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50",
      "product_quantity": "1,980 bottles",
      "reason_for_recall": "Presence of  foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.",
      "recall_initiation_date": "20170616",
      "center_classification_date": "20170803",
      "termination_date": "20200529",
      "report_date": "20170809",
      "code_info": "Lot #: HN7003"
    }
  ]
}