CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx on
Summary
The FDA issued a Class III for CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral 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-0458-2022
Action Date
2022-02-02
Status
Terminated
Category
drug
Product Description
CariFree sample boxes, contains one tube 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.
Lot/Code Info: Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).
Quantity Affected: 8 single tubes of lot 492106 and 50 single tubes of lot 492107
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-0458-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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