D-0458-2022 Class III Terminated
FDA drug recall D-0458-2022 was initiated by Dental Alliance Holdings LLC on December 3, 2021 and is designated Class III. Reason for recall: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. The recall status is terminated (terminated August 11, 2022). Affected quantity: 8 single tubes of lot 492106 and 50 single tubes of lot 492107.
Recall Details
- Product Type
- Drugs
- Report Date
- February 2, 2022
- Initiation Date
- December 3, 2021
- Termination Date
- August 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 single tubes of lot 492106 and 50 single tubes of lot 492107
Product Description
CariFree sample boxes, contains one tube 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.
Reason for Recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Distribution Pattern
Distributed nationwide with the United States
Code Information
Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).