{
  "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": "Terminated",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "SODIUM FLOURIDE"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "AvKARE"
        ],
        "product_ndc": [
          "42291-741"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "4874ee42-bfbe-02d5-e063-6394a90a2b6e"
        ],
        "spl_set_id": [
          "92fef2e0-f9f2-8b0f-e053-2995a90a096a"
        ],
        "package_ndc": [
          "42291-741-51"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0342291741515"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92868",
      "recalling_firm": "AVKARE LLC",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Affected product was distributed to nineteen (19) consignees within the united states.",
      "recall_number": "D-1146-2023",
      "product_description": "Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478",
      "product_quantity": "35,184 tubes",
      "reason_for_recall": "Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste",
      "recall_initiation_date": "20230811",
      "center_classification_date": "20230907",
      "termination_date": "20240429",
      "report_date": "20230913",
      "code_info": "Lot # P23025  Exp. 02/24/2025"
    }
  ]
}