{
  "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": "94634",
      "recalling_firm": "GlaxoSmithKline LLC",
      "address_1": "1011 N Arendell Ave",
      "address_2": "N/A",
      "postal_code": "27597-2309",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0544-2024",
      "product_description": "Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37",
      "product_quantity": "463 Cartons",
      "reason_for_recall": "Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.",
      "recall_initiation_date": "20240517",
      "center_classification_date": "20240606",
      "termination_date": "20250129",
      "report_date": "20240612",
      "code_info": "Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025",
      "more_code_info": ""
    }
  ]
}