{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pacific Palisades",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA213312"
        ],
        "brand_name": [
          "FYARRO"
        ],
        "generic_name": [
          "SIROLIMUS"
        ],
        "manufacturer_name": [
          "Aadi Bioscience, Inc."
        ],
        "product_ndc": [
          "80803-153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SIROLIMUS"
        ],
        "rxcui": [
          "2586863",
          "2586868"
        ],
        "spl_id": [
          "94544e08-d7c0-4154-aa40-46c5298c5528"
        ],
        "spl_set_id": [
          "0f9bb784-53e2-46f9-a65d-1c6c2a230eaf"
        ],
        "package_ndc": [
          "80803-153-50"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175550",
          "N0000175625",
          "N0000175624",
          "N0000175605",
          "N0000175076"
        ],
        "pharm_class_pe": [
          "Decreased Immunologic Activity [PE]"
        ],
        "pharm_class_epc": [
          "mTOR Inhibitor Immunosuppressant [EPC]",
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "mTOR Inhibitors [MoA]",
          "Protein Kinase Inhibitors [MoA]"
        ],
        "unii": [
          "W36ZG6FT64"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91019",
      "recalling_firm": "Aadi Bioscience",
      "address_1": "17383 W Sunset Blvd Ste A250",
      "address_2": "N/A",
      "postal_code": "90272-4181",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Within the U.S Market - PA, AL, KY, TN",
      "recall_number": "D-0059-2023",
      "product_description": "Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.",
      "product_quantity": "2,333 vials",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20221013",
      "center_classification_date": "20221114",
      "termination_date": "20230316",
      "report_date": "20221123",
      "code_info": "Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50."
    }
  ]
}