{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206751"
        ],
        "brand_name": [
          "METHYLPREDNISOLONE"
        ],
        "generic_name": [
          "METHYLPREDNISOLONE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-916",
          "68382-917",
          "68382-918",
          "68382-919"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPREDNISOLONE"
        ],
        "rxcui": [
          "197971",
          "197973",
          "259966",
          "328161",
          "762675"
        ],
        "spl_id": [
          "6cebff10-362f-41a7-8f66-3d9e878760fd"
        ],
        "spl_set_id": [
          "eaa9c932-c659-4ef6-bf5a-186545d87320"
        ],
        "package_ndc": [
          "68382-916-01",
          "68382-916-05",
          "68382-916-34",
          "68382-917-11",
          "68382-917-01",
          "68382-917-05",
          "68382-917-30",
          "68382-917-77",
          "68382-918-18",
          "68382-918-01",
          "68382-918-05",
          "68382-918-30",
          "68382-918-77",
          "68382-919-11",
          "68382-919-01",
          "68382-919-05",
          "68382-919-30",
          "68382-919-77"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "X4W7ZR7023"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82827",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1451-2019",
      "product_description": "MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India  NDC 68382-919-11",
      "product_quantity": "13,564 25-count bottles",
      "reason_for_recall": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
      "recall_initiation_date": "20190506",
      "center_classification_date": "20190701",
      "termination_date": "20210916",
      "report_date": "20190626",
      "code_info": "Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20."
    }
  ]
}