Reported Jan 9, 2019 · Terminated
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit…
Ultradent Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800
Is this the product you have?
- Enamelast Cool Mint/OT Varnish 5% NaF Mint Label
- Enamelast Unit Dose 200pk Cool MintEnamelast 5% Sodium Fluoride Unit Dose 200pk
- Kit - Cool Mint REF/UP 4352 Rx CONTENTS200 x 0.4 ml Unit Dose Label
- Enamelast Unit Dose 50pk Cool MintEnamelast 5% Sodium Fluoride Unit Dose 50pk
- Kit - Cool Mint REF/UP 4353 Rx CONTENTS50 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 MintEnamelast 5% Sodium Fluoride Unit Dose 50pk Kit -
- Variety Pack REF/UP 4353 Rx CONTENTS50 x 0.4
- ml Unit Dose Product UsageDescription: 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 UseEnamelast 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
- Lot codes and dates
- 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
- Amount recalled
- 1654 units
Where it was sold
Why it was recalled
Dental varnish has the possibility of having an unpleasant and off flavor.
This product could cause temporary or reversible health problems — stop using it.
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