{
  "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": [
          "QUALITY CHOICE EARWAX REMOVAL KIT",
          "QUALITY CHOICE EARWAX REMOVAL DROPS"
        ],
        "generic_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "manufacturer_name": [
          "Chain Drug Marketing Association, Inc."
        ],
        "product_ndc": [
          "63868-026",
          "63868-027"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "rxcui": [
          "702050"
        ],
        "spl_id": [
          "0c868adb-9999-5c7a-e063-6394a90a6638",
          "52f67d50-4482-6e0f-e063-6394a90a7877"
        ],
        "spl_set_id": [
          "ba8d71b5-7f1f-44a5-ac5b-1f7ceeb02875",
          "d8fd8102-114f-415d-9083-f98a63f9d1b3"
        ],
        "package_ndc": [
          "63868-026-15",
          "63868-027-16"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "31PZ2VAU81"
        ],
        "upc": [
          "0635515987623"
        ]
      },
      "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-0680-2026",
      "product_description": "QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.",
      "product_quantity": "15, 843 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) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.",
      "more_code_info": ""
    }
  ]
}