{
  "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": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA207934"
        ],
        "brand_name": [
          "EVEROLIMUS"
        ],
        "generic_name": [
          "EVEROLIMUS"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "49884-119",
          "49884-125",
          "49884-127",
          "49884-128"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EVEROLIMUS"
        ],
        "rxcui": [
          "845507",
          "845515",
          "998189",
          "1119400"
        ],
        "spl_id": [
          "b474c768-50e2-44da-accf-f1bd3d49ab20"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "49884-119-52",
          "49884-119-91",
          "49884-125-52",
          "49884-125-91",
          "49884-127-52",
          "49884-127-91",
          "49884-128-52",
          "49884-128-91"
        ],
        "is_original_packager": [
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        "nui": [
          "N0000175605",
          "N0000175076",
          "N0000182141",
          "N0000182137",
          "N0000175625",
          "N0000175624",
          "N0000175550"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]",
          "mTOR Inhibitor Immunosuppressant [EPC]"
        ],
        "pharm_class_moa": [
          "Protein Kinase Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "mTOR Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Immunologic Activity [PE]"
        ],
        "unii": [
          "9HW64Q8G6G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97866",
      "recalling_firm": "Endo USA, Inc.",
      "address_1": "9 Great Valley Pkwy",
      "address_2": "N/A",
      "postal_code": "19355-1304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0142-2026",
      "product_description": "Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91",
      "product_quantity": "2,035 cartons",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.",
      "recall_initiation_date": "20251010",
      "center_classification_date": "20251029",
      "report_date": "20251105",
      "code_info": "Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26"
    }
  ]
}