Recalls / Class III
Class IIID-0459-2022
Product
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.
- Affected lot / code info
- Lot #: 142017, exp. Date 06/22
Why it was recalled
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Recalling firm
- Firm
- Dental Alliance Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 812 Water Ave Ne, Albany, Oregon 97321-3074
Distribution
- Quantity
- 360 individual tubes of lot 142017.
- Distribution pattern
- Distributed nationwide with the United States
Timeline
- Recall initiated
- 2021-12-03
- FDA classified
- 2022-01-26
- Posted by FDA
- 2022-02-02
- Terminated
- 2022-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0459-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.