CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6
Summary
The FDA issued a Class III for CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium F by Dental Alliance Holdings LLC. Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label..
Details
Source
Drug Recall
External ID
D-0457-2022
Action Date
2022-02-02
Status
Terminated
Category
drug
Product Description
CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
Lot/Code Info: Lot #: 352110, 352111 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Quantity Affected: 90 single tubes of 352110 and 315 single tubes of 352111
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Distribution
Distributed nationwide with the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-03
Company
Albany, OR
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 100 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dental Alliance Holdings LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dental Alliance Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dental Alliance Holdings LLC have FDA actions?
Dental Alliance Holdings LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0457-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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