FDA recall Z-1182-2021

Sunstar Americas, Inc. · Class II · device

Product

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

Reason for recall

The product may be contaminated with Burkholderia cepacia

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-02-18
Report date
2021-03-17
Termination date
2024-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2021