{
  "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": "Huntsville",
      "state": "AL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040183"
        ],
        "brand_name": [
          "METHYLPREDNISOLONE"
        ],
        "generic_name": [
          "METHYLPREDNISOLONE"
        ],
        "manufacturer_name": [
          "Endo USA, Inc."
        ],
        "product_ndc": [
          "0603-4593"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE"
        ],
        "rxcui": [
          "259966",
          "762675"
        ],
        "spl_id": [
          "6b210f06-32c0-450a-ad2b-2d0827b06f7a"
        ],
        "spl_set_id": [
          "c84cf5e6-746d-41fb-b3d8-2c0b8ba989af"
        ],
        "package_ndc": [
          "0603-4593-21",
          "0603-4593-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0306034593212"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "X4W7ZR7023"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69233",
      "recalling_firm": "Qualitest Pharmaceuticals",
      "address_1": "120 Vintage Dr NE",
      "address_2": "N/A",
      "postal_code": "35811-8216",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1605-2014",
      "product_description": "MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)  and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL  35811",
      "product_quantity": "159,913 tablets",
      "reason_for_recall": "Subpotent; 6 month stability time point",
      "recall_initiation_date": "20140911",
      "center_classification_date": "20140922",
      "termination_date": "20160127",
      "report_date": "20141001",
      "code_info": "100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015"
    }
  ]
}