{
  "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": [
          "AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM",
          "AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS"
        ],
        "generic_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "manufacturer_name": [
          "Oaktree Products Inc.",
          "Oaktree Products Inc"
        ],
        "product_ndc": [
          "59256-001",
          "59256-836"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL",
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "rxcui": [
          "702050"
        ],
        "spl_id": [
          "52f59193-51cf-ad22-e063-6394a90a248a",
          "2f3946af-a3da-7032-e063-6294a90ad132"
        ],
        "spl_set_id": [
          "c9ad507b-341c-474f-aaa2-3c3a97a30dd8",
          "2922dde2-d082-437b-8f51-4a91ced20a58"
        ],
        "package_ndc": [
          "59256-001-02",
          "59256-836-34"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0749566001020",
          "0749566001013"
        ],
        "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-0682-2026",
      "product_description": "AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC  59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.",
      "product_quantity": "5,762 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)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.",
      "more_code_info": ""
    }
  ]
}