Drug 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.
D-0459-2022
Product summary
- Event
- Event 89152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 360 individual tubes of lot 142017.
- Official record key
drug-enforcement:D-0459-2022
Official wording
Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information: Lot #: 142017, exp. Date 06/22
Distribution pattern: Distributed nationwide with the United States
Derived failure modes
-
Potency or specification failure
Subpotent