{
  "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": "Gibbstown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "GELATO TOPICAL ANESTHETIC"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc"
        ],
        "product_ndc": [
          "68400-352"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "238910",
          "727988"
        ],
        "spl_id": [
          "0bf1220f-a6ad-8a62-e063-6394a90af47e"
        ],
        "spl_set_id": [
          "1f8431bb-f33c-4fd8-9472-9b59ffb5f18e"
        ],
        "package_ndc": [
          "68400-352-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "U3RSY48JW5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95854",
      "recalling_firm": "Keystone Industries",
      "address_1": "480 S Democrat Rd",
      "address_2": "",
      "postal_code": "08027-1239",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.",
      "recall_number": "D-0137-2025",
      "product_description": "Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.",
      "product_quantity": "",
      "reason_for_recall": "CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.",
      "recall_initiation_date": "20241114",
      "center_classification_date": "20241213",
      "termination_date": "20260423",
      "report_date": "20241225",
      "code_info": "Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone item No. 03-02319",
      "more_code_info": ""
    }
  ]
}