{
  "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": [
          "LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB"
        ],
        "generic_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "manufacturer_name": [
          "Cardinal Health 110 DBA Leader"
        ],
        "product_ndc": [
          "70000-0689"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "702050"
        ],
        "spl_id": [
          "1f7f89ab-ef7d-21dc-e063-6294a90ab82a"
        ],
        "spl_set_id": [
          "36c1408b-4287-4e9f-aa17-4f05add50038"
        ],
        "package_ndc": [
          "70000-0689-1",
          "70000-0688-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295143799",
          "0096295143782"
        ]
      },
      "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-0685-2026",
      "product_description": "LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.",
      "product_quantity": "5, 471 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) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.",
      "more_code_info": ""
    }
  ]
}