CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Reported: February 2, 2022 Initiated: December 3, 2021 #D-0459-2022
Product Description
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Details
- Recalling Firm
- Dental Alliance Holdings LLC
- Units Affected
- 360 individual tubes of lot 142017.
- Distribution
- Distributed nationwide with the United States
- Location
- Albany, OR
Frequently Asked Questions
What product was recalled? ▼
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.. Recalled by Dental Alliance Holdings LLC. Units affected: 360 individual tubes of lot 142017..
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-0459-2022.
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