{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA201578"
        ],
        "brand_name": [
          "SIROLIMUS"
        ],
        "generic_name": [
          "SIROLIMUS"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-653",
          "55111-654"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIROLIMUS"
        ],
        "rxcui": [
          "349208",
          "360110"
        ],
        "spl_id": [
          "f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b"
        ],
        "spl_set_id": [
          "2e6130e5-fa94-dcf8-605c-817bf396e93d"
        ],
        "package_ndc": [
          "55111-653-30",
          "55111-653-01",
          "55111-654-30",
          "55111-654-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111654018"
        ],
        "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": "74325",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1063-2016",
      "product_description": "Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01",
      "product_quantity": "9,330 bottles",
      "reason_for_recall": "Failed impurities/degradation: out of specification result for impurity secorapamycin.",
      "recall_initiation_date": "20160603",
      "center_classification_date": "20160705",
      "termination_date": "20170407",
      "report_date": "20160713",
      "code_info": "Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16"
    }
  ]
}