Dental Alliance Holdings LLC: Drug Recall
Recall #D-0459-2022 · 12/03/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0459-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Dental Alliance Holdings LLC
- Status
- Terminated
- Date Initiated
- 12/03/2021
- Location
- Albany, OR, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 individual tubes of lot 142017.
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
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.
Distribution Pattern
Distributed nationwide with the United States
Other Recalls by Dental Alliance Holdings LLC
- Class III: Low Risk 12/03/2021
- Class III: Low Risk 12/03/2021
- Class III: Low Risk 12/03/2021
- Class III: Low Risk 12/03/2021
- Class III: Low Risk 12/03/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.