Drug product
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 Distributed in 12-pk/cases
D-0453-2022
Product summary
- Event
- Event 89152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
- Official record key
drug-enforcement:D-0453-2022
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