{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cambridge",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA088390"
        ],
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        ],
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        "product_ndc": [
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          "66312-181"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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          "EPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
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          "66312-176-16"
        ],
        "is_original_packager": [
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        "unii": [
          "V13007Z41A",
          "30Q7KI53AK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98080",
      "recalling_firm": "Novocol Pharmaceutical of Canada, Inc.",
      "address_1": "25 Wolseley Crt",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-0228-2026",
      "product_description": "2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.",
      "product_quantity": "18,789 cartons- 50 cartridges /carton",
      "reason_for_recall": "Defective container: cracked/broken cartridges",
      "recall_initiation_date": "20251031",
      "center_classification_date": "20251212",
      "report_date": "20251224",
      "code_info": "Lot: D05337B, expires: 06-30-2027",
      "more_code_info": ""
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}