{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "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"
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        "spl_id": [
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        ],
        "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": "67606",
      "recalling_firm": "Viiv Healthcare Company",
      "address_1": "5 Moore Dr",
      "address_2": "N/A",
      "postal_code": "27709-0143",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide including Puerto Rico",
      "recall_number": "D-1185-2014",
      "product_description": "Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx  Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709.  Made in Japan. NDC 49702-228-13",
      "product_quantity": "1,056 bottles",
      "reason_for_recall": "Cross Contamination with Other Products: Product contains Promacta (eltrombopag).",
      "recall_initiation_date": "20140211",
      "center_classification_date": "20140401",
      "termination_date": "20140821",
      "report_date": "20140409",
      "code_info": "Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15"
    }
  ]
}