FDA recall D-0458-2022

Dental Alliance Holdings LLC · Class III · drug

Product

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

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-0458-2022