{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Telford",
      "address_1": "306 Keystone Dr",
      "reason_for_recall": "One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.",
      "address_2": "Unit B",
      "product_quantity": "528",
      "code_info": "lot # H13136, exp. August 2014.",
      "center_classification_date": "20140716",
      "distribution_pattern": "US distribution to NY and CA",
      "state": "PA",
      "product_description": "Calcium Hydroxide Powder, USP    For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.",
      "report_date": "20140723",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Axcentria Pharmaceuticals, LLC",
      "recall_number": "Z-2069-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68480",
      "termination_date": "20161128",
      "recall_initiation_date": "20140605",
      "postal_code": "18969",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}