{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA080352"
        ],
        "brand_name": [
          "PREDNISONE"
        ],
        "generic_name": [
          "PREDNISONE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-0017",
          "0054-4741",
          "0054-4742",
          "0054-4728",
          "0054-0018",
          "0054-0019",
          "0054-3722",
          "0054-3721",
          "0054-8739",
          "0054-8740",
          "0054-8724"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PREDNISONE"
        ],
        "rxcui": [
          "198144",
          "198145",
          "198146",
          "198148",
          "205301",
          "312615",
          "312617",
          "315187"
        ],
        "spl_id": [
          "523ad364-8d95-4679-9290-446d61f36eb5"
        ],
        "spl_set_id": [
          "3115aef0-fd50-4ec8-a064-3effb695f3f2"
        ],
        "package_ndc": [
          "0054-4741-25",
          "0054-4741-31",
          "0054-4742-25",
          "0054-4728-25",
          "0054-4728-31",
          "0054-0017-25",
          "0054-0017-29",
          "0054-0017-20",
          "0054-0018-25",
          "0054-0018-29",
          "0054-0018-20",
          "0054-0019-20",
          "0054-0019-25",
          "0054-3722-63",
          "0054-3722-50",
          "0054-3721-44",
          "0054-8739-25",
          "0054-8740-25",
          "0054-8724-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300543722507"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "VB0R961HZT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65467",
      "recalling_firm": "Boehringer Ingelheim Roxane Inc",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-882-2013",
      "product_description": "Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20",
      "product_quantity": "14,619 cartons",
      "reason_for_recall": "Labeling: Missing Label; missing label on blister card",
      "recall_initiation_date": "20130614",
      "center_classification_date": "20130812",
      "termination_date": "20140623",
      "report_date": "20130821",
      "code_info": "The affected product consists of lot #261739A, expiration date OCT 2014.",
      "more_code_info": ""
    }
  ]
}