{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennsauken",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "CETACAINE ANESTHETIC"
        ],
        "generic_name": [
          "BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Cetylite Industries, Inc."
        ],
        "product_ndc": [
          "10223-0202",
          "10223-0225",
          "10223-0226"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOCAINE",
          "BUTAMBEN",
          "TETRACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "543786",
          "543789"
        ],
        "spl_id": [
          "66344c64-2439-4a34-8eb4-707e707c8ab1"
        ],
        "spl_set_id": [
          "89f262a4-a41b-41d7-806b-61b9b89542f0"
        ],
        "package_ndc": [
          "10223-0202-2",
          "10223-0202-4",
          "10223-0202-5",
          "10223-0202-6",
          "10223-0202-7",
          "10223-0202-8",
          "10223-0225-1",
          "10223-0226-1",
          "10223-0202-3"
        ],
        "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",
          "5NF5D4OPCI",
          "EFW857872Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66012",
      "recalling_firm": "Cetylite Industries, Inc.",
      "address_1": "9051 River Road",
      "address_2": "N/A",
      "postal_code": "08110-3203",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-019-2014",
      "product_description": "Cetacaine Liquid Topical Anesthetic,  Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110       -",
      "product_quantity": "30 g - 11403 units; 14 g  - 7338 units 14 g kit - 200 units",
      "reason_for_recall": "Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit  at the 21 month stability test point.",
      "recall_initiation_date": "20130402",
      "center_classification_date": "20131126",
      "termination_date": "20140801",
      "report_date": "20131204",
      "code_info": "Lot 470  exp.  04/13, 471 exp. 06/13, 472 exp.  10/13"
    }
  ]
}