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.
FDA Recall Z-0690-2019 · Posted None
Recalling FirmUltradent Products, Inc.
Recall StatusTerminated
Product CodeLBH
Date Initiated2018-07-12
Date Terminated2019-02-19
Product Quantity1654 units
Reason for Recall
Dental varnish has the possibility of having an unpleasant and off flavor.
Firm Action
On July 3, 2018, the firm sent an URGENT PRODUCT CORRECTION Notification to customers via UPS informing them that the Cool Mint flavor Fluoride Varnish has the possibility of having an unpleasant and off flavor, atypical of the refreshing cool mint flavor that they are used to.
If the customer has any questions regarding this correction or directions to the actions required, please contact Adam Black at 801-553-4425 or Karen Kakunes at 801-553-4366.
Customer are instructed to take the following actions for tracing and documentation purposes:
-Discard remaining inventory of Enamelast Cool Mint flavor product from the identified part and lot number above.
-Respond to this letter by completing the "RETURN RESPONSE form and returning it to Ultradent Products, Inc., to the attention of Adam Black with the contact information provided.
Please fill out and return via fax or email to Adam Black at Ultradent Products Inc.
Fax: 801-553-4609 or E-mail: [email protected]
Root Cause
Mixed-up of materials/components
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.