{
  "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": "Completed",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "AMERICAINE"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "Insight Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "63736-378"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "211315",
          "360349"
        ],
        "spl_id": [
          "d727db6e-b2c9-4bf6-96c5-751713baaf6a"
        ],
        "spl_set_id": [
          "4fd14452-0285-40c4-b835-36935c2056b2"
        ],
        "package_ndc": [
          "63736-378-02"
        ],
        "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"
        ],
        "upc": [
          "363736378820"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93691",
      "recalling_firm": "Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company",
      "address_1": "660 White Plains Rd Ste 250",
      "address_2": "N/A",
      "postal_code": "10591-5171",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0236-2024",
      "product_description": "Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7",
      "product_quantity": "34,704 cans",
      "reason_for_recall": "Chemical Contamination: presence of benzene",
      "recall_initiation_date": "20231221",
      "center_classification_date": "20240117",
      "report_date": "20240124",
      "code_info": "Lot # 1A16420, exp. date 01/31/2025"
    }
  ]
}