CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Reported: February 2, 2022 Initiated: December 3, 2021 #D-0455-2022
Product Description
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Details
- Recalling Firm
- Dental Alliance Holdings LLC
- Units Affected
- 180 single tube of lot 272109 and 180 single tube count of lot 272110
- Distribution
- Distributed nationwide with the United States
- Location
- Albany, OR
Frequently Asked Questions
What product was recalled? ▼
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.. Recalled by Dental Alliance Holdings LLC. Units affected: 180 single tube of lot 272109 and 180 single tube count of lot 272110.
Why was this product recalled? ▼
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 2, 2022. Severity: Low. Recall number: D-0455-2022.
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