{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA086195"
        ],
        "brand_name": [
          "PROCTOFOAM"
        ],
        "generic_name": [
          "PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "0037-6822"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE ACETATE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "828362",
          "828364"
        ],
        "spl_id": [
          "d63033a1-dca0-44f9-a6f3-210e38c2691e"
        ],
        "spl_set_id": [
          "3831e931-ec0a-11e3-ac10-0800200c9a66"
        ],
        "package_ndc": [
          "0037-6822-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3X7931PO74",
          "88AYB867L5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89415",
      "recalling_firm": "Mylan Pharmaceuticals Inc",
      "address_1": "3711 Collins Ferry Rd",
      "address_2": "",
      "postal_code": "26505-2362",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Recalled product was distributed nationwide within the United States.",
      "recall_number": "D-0452-2022",
      "product_description": "Proctofoam HC (hydrocortisone acetate 1% and  pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120,   NDC 0037-6822-10.",
      "product_quantity": "233,199/10 g aerosol containers",
      "reason_for_recall": "cGMP deficiencies",
      "recall_initiation_date": "20220121",
      "center_classification_date": "20220125",
      "termination_date": "20240312",
      "report_date": "20220202",
      "code_info": "Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023",
      "more_code_info": ""
    }
  ]
}