Drug product
CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
D-0455-2022
Product summary
- Event
- Event 89152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 180 single tube of lot 272109 and 180 single tube count of lot 272110
- Official record key
drug-enforcement:D-0455-2022
Official wording
Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information: Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Distribution pattern: Distributed nationwide with the United States
Derived failure modes
-
Potency or specification failure
Subpotent