{
  "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": "Cambridge",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA088390"
        ],
        "brand_name": [
          "LIDOCAINE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Darby Dental Supply, LLC"
        ],
        "product_ndc": [
          "66467-9730"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBMUCOSAL"
        ],
        "substance_name": [
          "EPINEPHRINE BITARTRATE",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1293648"
        ],
        "spl_id": [
          "e017e74c-d217-472f-be32-7d21d7f129ec"
        ],
        "spl_set_id": [
          "e5ed4c2a-e320-48cf-a2fd-61d48481c624"
        ],
        "package_ndc": [
          "66467-9730-5",
          "0362-9023-05",
          "42756-1030-5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "30Q7KI53AK",
          "V13007Z41A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65979",
      "recalling_firm": "Novocol Pharmaceutical of Canada",
      "address_1": "25 Wolseley Court",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide and Canada",
      "recall_number": "D-923-2013",
      "product_description": "Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each,  NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada,  66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.",
      "product_quantity": "12,497 Boxes",
      "reason_for_recall": "Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.",
      "recall_initiation_date": "20130814",
      "center_classification_date": "20130826",
      "termination_date": "20140107",
      "report_date": "20130904",
      "code_info": "Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013",
      "more_code_info": ""
    }
  ]
}