{
  "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": "Bronx",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA085025"
        ],
        "brand_name": [
          "HYDROCORTISONE"
        ],
        "generic_name": [
          "HYDROCORTISONE"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-004",
          "45802-014"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "103401",
          "310891"
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        "spl_id": [
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        "spl_set_id": [
          "7ba59aa6-b828-4048-bf86-90c90d9894a0"
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        "package_ndc": [
          "45802-004-02",
          "45802-004-03",
          "45802-014-02",
          "45802-014-05"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80049",
      "recalling_firm": "Perrigo New York",
      "address_1": "1700 Bathgate Ave",
      "address_2": "",
      "postal_code": "10457-7512",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide including Puerto Rico.",
      "recall_number": "D-0817-2018",
      "product_description": "Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02",
      "product_quantity": "571,632 tubes",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20180507",
      "center_classification_date": "20180516",
      "termination_date": "20181210",
      "report_date": "20180523",
      "code_info": "Lot Numbers:  7AT0283V, exp. 11/18  7AT0284V, exp. 11/18  7AT0285V, exp. 11/18  7FT0460, exp. 05/19  7FT0461, exp. 05/19  7GT0465, exp. 06/19  7GT0466, exp. 06/19  7JT0390, exp. 08/19  7JT0392, exp. 08/19  7KT0588, exp. 09/19  7KT0589, exp. 09/19",
      "more_code_info": ""
    }
  ]
}