{
  "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": "Salisbury",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040189"
        ],
        "brand_name": [
          "METHYLPREDNISOLONE"
        ],
        "generic_name": [
          "METHYLPREDNISOLONE"
        ],
        "manufacturer_name": [
          "Jubilant Cadista Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59746-001",
          "59746-002",
          "59746-003",
          "59746-015"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE"
        ],
        "rxcui": [
          "197971",
          "197973",
          "259966",
          "328161",
          "762675"
        ],
        "spl_id": [
          "6887bc3b-fb6d-46b1-a9e4-6115c2472ecc"
        ],
        "spl_set_id": [
          "7bf4d3d3-3f8a-4e20-9194-061658efca61"
        ],
        "package_ndc": [
          "59746-001-06",
          "59746-001-03",
          "59746-002-04",
          "59746-002-06",
          "59746-003-14",
          "59746-015-04"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359746015046",
          "0359746001063",
          "0359746003142",
          "0359746002046"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "X4W7ZR7023"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80951",
      "recalling_firm": "Jubilant Cadista Pharmaceuticals, Inc.",
      "address_1": "207 Kiley Dr",
      "address_2": "N/A",
      "postal_code": "21801-2249",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-1205-2018",
      "product_description": "MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only.  Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03",
      "product_quantity": "89,722 blister pack",
      "reason_for_recall": "Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.",
      "recall_initiation_date": "20180827",
      "center_classification_date": "20180921",
      "termination_date": "20191008",
      "report_date": "20180926",
      "code_info": "Lot # 17P0078, exp. date 12/2018"
    }
  ]
}