Drug product
CTx7 Kit, contains one tube 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 one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
D-0454-2022
Product summary
- Event
- Event 89152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 single tubes of lot 192107 and 3 single tubes of 192108
- Official record key
drug-enforcement:D-0454-2022
Official wording
Reason: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Code information: Lot #: 192107 and lot 192108 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