FDA recall D-0459-2022

Product

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 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

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-0459-2022