{
  "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": "Ongoing",
      "city": "Belle Plaine",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M014"
        ],
        "brand_name": [
          "TOPCARE EARWAX REMOVAL KIT"
        ],
        "generic_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "manufacturer_name": [
          "TOPCO ASSOCIATES LLC"
        ],
        "product_ndc": [
          "36800-835"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "rxcui": [
          "702050"
        ],
        "spl_id": [
          "2f394074-9ba2-6dff-e063-6294a90a2cad"
        ],
        "spl_set_id": [
          "890cc9b6-41a5-480a-bc94-45c8d4fdeef3"
        ],
        "package_ndc": [
          "36800-835-33",
          "36800-835-34"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0036800776913"
        ],
        "unii": [
          "31PZ2VAU81"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99278",
      "recalling_firm": "Bell Pharmaceuticals, Inc",
      "address_1": "200 W Beaver St",
      "address_2": "",
      "postal_code": "56011-1894",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S Nationwide",
      "recall_number": "D-0681-2026",
      "product_description": "TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.",
      "product_quantity": "16,156 units",
      "reason_for_recall": "SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).",
      "recall_initiation_date": "20260625",
      "center_classification_date": "20260714",
      "report_date": "20260722",
      "code_info": "Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.",
      "more_code_info": ""
    }
  ]
}