{
  "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": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81407",
      "recalling_firm": "Ultradent Products, Inc.",
      "address_1": "505 W 10200 S",
      "address_2": "N/A",
      "postal_code": "84095-3800",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY    OUS: Germany, Italy, Malaysia, and Poland",
      "recall_number": "Z-0690-2019",
      "product_description": "Enamelast Cool Mint/OT Varnish 5% NaF Mint    Label Enamelast Unit Dose 200pk Cool Mint:  Enamelast 5% Sodium Fluoride  Unit Dose 200pk Kit - Cool Mint    REF/UP 4352  Rx  CONTENTS:  200 x 0.4 ml Unit Dose      Label Enamelast Unit Dose 50pk Cool Mint:  Enamelast 5% Sodium Fluoride  Unit Dose 50pk Kit - Cool Mint    REF/UP 4353  Rx  CONTENTS:  50 x 0.4 ml Unit Dose  Manufactured by Ultradent Products Inc.    ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint:  Enamelast 5% Sodium Fluoride  Unit Dose 50pk Kit - Variety Pack    REF/UP 4353  Rx  CONTENTS:  50 x 0.4 ml Unit Dose      Product Usage:  Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.",
      "product_quantity": "1654 units",
      "reason_for_recall": "Dental varnish has the possibility of having an unpleasant and off flavor.",
      "recall_initiation_date": "20180712",
      "center_classification_date": "20190103",
      "termination_date": "20190219",
      "report_date": "20190109",
      "code_info": "Part No.    Description                                                       Lot No.  4352          Enamelast Unit Dose 200pk   Cool Mint        BFS7K  4353          Enamelast Unit Dose 50pk   Cool Mint          BFPX5  4368          Enamelast Unit Dose 200pk   Variety Pack   BFRJZ, BFTQG  4575          OEM MMM Varnish Mint 200pk                      BFLSB                    Confidential   private label customer  3380          OEM Contract CG Varnish Kit Mint 12pk        BFH9D                    Confidential   private label customer"
    }
  ]
}