Ultradent Recalls Enamelast Fluoride Varnish Due to Off-Flavor Complaints
Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to an unpleasant flavor, which is a cosmetic or quality defect rather than a safety hazard. No injuries, illnesses, or serious health risks are reported or implied in the source text.
Plain-English summary
Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish, a dental product used to treat tooth hypersensitivity. The recall involves 1,654 units of the product, including 200-pack and 50-pack kits in Cool Mint and Variety Pack configurations, as well as specific OEM private label lots.
The recall was initiated because the dental varnish has the possibility of having an unpleasant and off flavor. The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to Germany, Italy, Malaysia, and Poland.
Consumers and dental professionals who have purchased or received these specific lots should stop using the product and contact Ultradent Products, Inc. for further instructions or a refund. The specific lot numbers affected are BFS7K, BFPX5, BFRJZ, BFTQG, BFLSB, and BFH9D.
The recalled product
- Product
- 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…
- Manufacturer
- Ultradent Products, Inc.
- Category
- Medical Device — Dental Varnish
- Hazard
- Affected units
- 1,654
Distribution
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