{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Gibbstown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "BURKHART TOPICAL ANESTHETIC"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "Burkhart Dental Supply Inc"
        ],
        "product_ndc": [
          "43498-310"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "238910"
        ],
        "spl_id": [
          "2b485a83-16c9-21a7-e063-6394a90a92f0"
        ],
        "spl_set_id": [
          "867cef7b-fe6e-4a45-87c1-35579a681c6c"
        ],
        "package_ndc": [
          "43498-310-30"
        ],
        "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": "99076",
      "recalling_firm": "Keystone Industries",
      "address_1": "480 S Democrat Rd",
      "address_2": "",
      "postal_code": "08027-1239",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0603-2026",
      "product_description": "Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30",
      "product_quantity": "150 units",
      "reason_for_recall": "Defective container:may contain bottles with incomplete seals",
      "recall_initiation_date": "20260521",
      "center_classification_date": "20260618",
      "report_date": "20260624",
      "code_info": "BNZ-001917, Exp 04/15/2029",
      "more_code_info": ""
    }
  ]
}