{
  "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": "Foster City",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021752"
        ],
        "brand_name": [
          "TRUVADA"
        ],
        "generic_name": [
          "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE"
        ],
        "manufacturer_name": [
          "Gilead Sciences, Inc"
        ],
        "product_ndc": [
          "61958-0701",
          "61958-0703",
          "61958-0704",
          "61958-0705"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMTRICITABINE",
          "TENOFOVIR DISOPROXIL FUMARATE"
        ],
        "rxcui": [
          "476556",
          "639888",
          "1744001",
          "1744003",
          "1744005",
          "1744007",
          "1744009",
          "1744011"
        ],
        "spl_id": [
          "32422ee8-1cdc-4305-bb3e-0458472513fc"
        ],
        "spl_set_id": [
          "54e82b13-a037-49ed-b4b3-030b37c0ecdd"
        ],
        "package_ndc": [
          "61958-0701-1",
          "61958-0703-1",
          "61958-0704-1",
          "61958-0705-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175462",
          "M0015066",
          "N0000009947"
        ],
        "pharm_class_epc": [
          "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"
        ],
        "pharm_class_cs": [
          "Nucleosides [CS]"
        ],
        "pharm_class_moa": [
          "Nucleoside Reverse Transcriptase Inhibitors [MoA]"
        ],
        "unii": [
          "OTT9J7900I",
          "G70B4ETF4S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69414",
      "recalling_firm": "Gilead Sciences, Inc.",
      "address_1": "333 Lakeside Dr",
      "address_2": "",
      "postal_code": "94404-1147",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0013-2015",
      "product_description": "Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1",
      "product_quantity": "10,317 bottles",
      "reason_for_recall": "Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.",
      "recall_initiation_date": "20140930",
      "center_classification_date": "20141009",
      "termination_date": "20150511",
      "report_date": "20141015",
      "code_info": "TRUVADA (NDA 21-752; NDC 61958-0701-1)  Lot# 002808, Expiration Date: 31 December 2017",
      "more_code_info": ""
    }
  ]
}