{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA086195"
        ],
        "brand_name": [
          "PROCTOFOAM"
        ],
        "generic_name": [
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        ],
        "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"
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0037-6822-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3X7931PO74",
          "88AYB867L5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0529-2021",
      "product_description": "Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey",
      "product_quantity": "834 aerosol containers",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "33119"
    }
  ]
}