{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA201578"
        ],
        "brand_name": [
          "SIROLIMUS"
        ],
        "generic_name": [
          "SIROLIMUS"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-915"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIROLIMUS"
        ],
        "rxcui": [
          "349208"
        ],
        "spl_id": [
          "3ccedad8-85eb-c609-e063-6294a90a7e2d"
        ],
        "spl_set_id": [
          "5df60452-2b16-4ce9-8c29-48798a59d718"
        ],
        "package_ndc": [
          "68084-915-95",
          "68084-915-25"
        ],
        "original_packager_product_ndc": [
          "55111-653"
        ],
        "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": "88650",
      "recalling_firm": "American Health Packaging",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA",
      "recall_number": "D-0813-2021",
      "product_description": "Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25",
      "product_quantity": "290 cartons",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20210512",
      "center_classification_date": "20210920",
      "termination_date": "20220825",
      "report_date": "20210929",
      "code_info": "Lot #: 1000789, Exp. Date 10/31/2022",
      "more_code_info": ""
    }
  ]
}