{
  "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 II",
      "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": "75260",
      "recalling_firm": "West-Ward Pharmaceutical",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0008-2017",
      "product_description": "PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ  07724, NDC 0054-4741-25.",
      "product_quantity": "15,109 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.",
      "recall_initiation_date": "20161003",
      "center_classification_date": "20161006",
      "termination_date": "20171218",
      "report_date": "20161012",
      "code_info": "Lot # 660621A, Exp 01/31/18"
    }
  ]
}