{
  "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": "Ongoing",
      "city": "Foster City",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA208341"
        ],
        "brand_name": [
          "SOFOSBUVIR AND VELPATASVIR"
        ],
        "generic_name": [
          "VELPATASVIR AND SOFOSBUVIR"
        ],
        "manufacturer_name": [
          "Asegua Therapeutics LLC"
        ],
        "product_ndc": [
          "72626-2701"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VELPATASVIR",
          "SOFOSBUVIR"
        ],
        "rxcui": [
          "1799212"
        ],
        "spl_id": [
          "314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d"
        ],
        "spl_set_id": [
          "d0c1a945-4440-4b5c-81aa-693ed3db597c"
        ],
        "package_ndc": [
          "72626-2701-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000191256",
          "N0000190113",
          "N0000185503",
          "N0000190107",
          "N0000190108",
          "N0000190109",
          "N0000191493",
          "N0000191258"
        ],
        "pharm_class_epc": [
          "Hepatitis C Virus NS5A Inhibitor [EPC]",
          "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Breast Cancer Resistance Protein Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]",
          "Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]",
          "RNA Replicase Inhibitors [MoA]"
        ],
        "unii": [
          "KCU0C7RS7Z",
          "WJ6CA3ZU8B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96434",
      "recalling_firm": "ASEGUA THERAPEUTICS LLC",
      "address_1": "333 Lakeside Dr",
      "address_2": "N/A",
      "postal_code": "94404-1147",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0313-2025",
      "product_description": "Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1",
      "product_quantity": "18,541 cartons.",
      "reason_for_recall": "Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.",
      "recall_initiation_date": "20250307",
      "center_classification_date": "20250407",
      "report_date": "20250416",
      "code_info": "Lot# 24ASV002UA, Exp Date: 6/30/2028"
    }
  ]
}