Dental Alliance Holdings LLC: Drug Recall
Recall #D-0457-2022 · 12/03/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0457-2022
- 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
- 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.
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.
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.