Drug product
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.
D-0457-2022
Product summary
- Event
- Event 89152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 90 single tubes of 352110 and 315 single tubes of 352111
- Official record key
drug-enforcement:D-0457-2022
Official wording
Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information: Lot #: 352110, 352111 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