FDA recall Z-0661-2020

Young Dental Manufacturing Co, LLC · Class II · device

Product

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Reason for recall

Product shelf life may be shorter than that indicated on the label.

Distribution

US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.

Key facts

Status
Ongoing
Initiation date
2019-10-30
Report date
2019-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2020