{
  "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": "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": [
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        ],
        "package_ndc": [
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          "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": "94535",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0504-2024",
      "product_description": "Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01",
      "product_quantity": "1,176 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20240501",
      "center_classification_date": "20240521",
      "report_date": "20240529",
      "code_info": "Lot H2200493; Exp 6/30/2025",
      "more_code_info": ""
    }
  ]
}