{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "REMEDY ANTIFUNGAL"
        ],
        "generic_name": [
          "MICONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-169"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MICONAZOLE NITRATE"
        ],
        "rxcui": [
          "998461"
        ],
        "spl_id": [
          "425303b5-9f9c-efc3-e063-6294a90ae594"
        ],
        "spl_set_id": [
          "021b4a31-d7f6-4921-b4b1-cbe832eecd93"
        ],
        "package_ndc": [
          "53329-169-79"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0080196528564"
        ],
        "unii": [
          "VW4H1CYW1K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93227",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0091-2024",
      "product_description": "Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79",
      "product_quantity": "",
      "reason_for_recall": "CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.",
      "recall_initiation_date": "20231004",
      "center_classification_date": "20231107",
      "termination_date": "20240930",
      "report_date": "20231115",
      "code_info": "Lot 007782, Exp 08/31/2024",
      "more_code_info": ""
    }
  ]
}