FDA-Device2021-03-17Class II

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.

Sunstar Americas, Inc.
Hazard

The product may be contaminated with Burkholderia cepacia

Sold states
US Nationwide distribution.
Affected count
56960 bottles
Manufactured in
301 E Central Rd, Schaumburg, IL, United States
Products
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.

Official notice

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

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