FDA recall D-0456-2022

Product

CTx26 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 two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Reason for recall

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Distribution

Distributed nationwide with the United States

Key facts

Status

Terminated

Initiation date

2021-12-03

Report date

2022-02-02

Termination date

2022-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Albany, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2022