{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Zebulon",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA204790"
        ],
        "brand_name": [
          "TIVICAY"
        ],
        "generic_name": [
          "DOLUTEGRAVIR SODIUM"
        ],
        "manufacturer_name": [
          "ViiV Healthcare Company"
        ],
        "product_ndc": [
          "49702-226",
          "49702-255",
          "49702-227",
          "49702-228"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOLUTEGRAVIR SODIUM"
        ],
        "rxcui": [
          "1433873",
          "1433879",
          "1796077",
          "1796079",
          "1796081",
          "1796083",
          "2374562",
          "2374566"
        ],
        "spl_id": [
          "a9175b83-2200-4bd2-9ee3-52095b5d2657"
        ],
        "spl_set_id": [
          "63df5af3-b8ac-4e76-9830-2dbb340af922"
        ],
        "package_ndc": [
          "49702-255-37",
          "49702-226-13",
          "49702-227-13",
          "49702-228-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349702227132",
          "0349702226135",
          "0349702228139"
        ],
        "unii": [
          "1Q1V9V5WYQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90166",
      "recalling_firm": "GlaxoSmithKline LLC",
      "address_1": "1011 N Arendell Ave",
      "address_2": "",
      "postal_code": "27597-2309",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-0896-2022",
      "product_description": "Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.",
      "product_quantity": "328 bottles",
      "reason_for_recall": "Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.",
      "recall_initiation_date": "20220513",
      "center_classification_date": "20220525",
      "termination_date": "20230817",
      "report_date": "20220601",
      "code_info": "Lot: 2A9E, Exp 1/2027",
      "more_code_info": ""
    }
  ]
}