FDA recall Z-1697-2023

Young Dental Manufacturing I, LLC · Class II · device

Product

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

Reason for recall

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

Distribution

US distribution to Florida, Nevada, and Pennsylvania.

Key facts

Status
Ongoing
Initiation date
2023-05-23
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2023