{
  "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": "East Hanover",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA050715"
        ],
        "brand_name": [
          "NEORAL"
        ],
        "generic_name": [
          "CYCLOSPORINE"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0246",
          "0078-0248",
          "0078-0274"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CYCLOSPORINE"
        ],
        "rxcui": [
          "241834",
          "835886",
          "835894",
          "835899",
          "835909",
          "835911"
        ],
        "spl_id": [
          "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b"
        ],
        "spl_set_id": [
          "94461af3-11f1-4670-95d4-2965b9538ae3"
        ],
        "package_ndc": [
          "0078-0246-61",
          "0078-0246-15",
          "0078-0248-61",
          "0078-0248-15",
          "0078-0274-22"
        ],
        "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90862",
      "recalling_firm": "Novartis Pharmaceuticals Corporation",
      "address_1": "1 Health Plz",
      "address_2": "N/A",
      "postal_code": "07936-1016",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1543-2022",
      "product_description": "Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.",
      "product_quantity": "132,999 cartons",
      "reason_for_recall": "CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.",
      "recall_initiation_date": "20220916",
      "center_classification_date": "20220926",
      "termination_date": "20240311",
      "report_date": "20221005",
      "code_info": "Lot # APCD162, Exp. 01/2023"
    }
  ]
}