{
  "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": [
          "QUALA TOPICAL ANESTHETIC GEL"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "National Distribution & Contracting, Inc"
        ],
        "product_ndc": [
          "43128-034"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "238910"
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        "spl_id": [
          "4d3b1eba-bdaa-54fd-e063-6394a90a7807"
        ],
        "spl_set_id": [
          "9f94b65d-47e3-9c6b-e053-2a95a90aa1f8"
        ],
        "package_ndc": [
          "43128-034-30"
        ],
        "is_original_packager": [
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        ],
        "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-0601-2026",
      "product_description": "Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.",
      "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-001921, EXP 04/15/2029",
      "more_code_info": ""
    }
  ]
}