{
  "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": "Terminated",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA211406"
        ],
        "brand_name": [
          "SIROLIMUS"
        ],
        "generic_name": [
          "SIROLIMUS"
        ],
        "manufacturer_name": [
          "Apotex Corp"
        ],
        "product_ndc": [
          "60505-6197"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SIROLIMUS"
        ],
        "rxcui": [
          "314230"
        ],
        "spl_id": [
          "5fb6d644-aae8-0bcc-d9ce-170dff1c4b44"
        ],
        "spl_set_id": [
          "9f64692d-2a18-ffcb-c572-0f218a71ca67"
        ],
        "package_ndc": [
          "60505-6197-2"
        ],
        "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": "90114",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "N/A",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0881-2022",
      "product_description": "Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2",
      "product_quantity": "2353 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.",
      "recall_initiation_date": "20220503",
      "center_classification_date": "20220518",
      "termination_date": "20231005",
      "report_date": "20220525",
      "code_info": "Lot: RZ1598, exp. date 02/2023",
      "more_code_info": ""
    }
  ]
}