{
  "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": "North York",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA065040"
        ],
        "brand_name": [
          "CYCLOSPORINE"
        ],
        "generic_name": [
          "CYCLOSPORINE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0133",
          "60505-0134"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CYCLOSPORINE"
        ],
        "rxcui": [
          "197553",
          "328160"
        ],
        "spl_id": [
          "aa39e91b-f23e-69c8-e400-1f896c77b8e2"
        ],
        "spl_set_id": [
          "bfca7088-fe93-abb9-3ec3-e6f5710a69c6"
        ],
        "package_ndc": [
          "60505-0133-0",
          "60505-0133-2",
          "60505-0133-1",
          "60505-0134-0",
          "60505-0134-2",
          "60505-0134-1",
          "3605050134"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175457",
          "N0000175458",
          "N0000182141",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Calcineurin Inhibitor Immunosuppressant [EPC]"
        ],
        "pharm_class_moa": [
          "Calcineurin Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "83HN0GTJ6D"
        ],
        "upc": [
          "360505013401"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76402",
      "recalling_firm": "Apotex Inc.",
      "address_1": "150 Signet Dr",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide",
      "recall_number": "D-0475-2017",
      "product_description": "CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0",
      "product_quantity": "19,584 bottles",
      "reason_for_recall": "Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.",
      "recall_initiation_date": "20170203",
      "center_classification_date": "20170223",
      "termination_date": "20220615",
      "report_date": "20170301",
      "code_info": "Lot MJ9837, Exp 07/2017.  NDC 60505-0134-0, UPC 360505013401"
    }
  ]
}