FDA Recall
Terminated
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.
Recall: Z-1182-2021
·
Initiated February 18, 2021
Recall
- Recall Number
- Z-1182-2021
- Event Number
- 87371
- Firm
- Sunstar Americas, Inc.
- FEI Number
- 1413787
- Product Code
- LFD
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 18, 2021
- Terminated
- September 30, 2024
- Address
- 301 E Central Rd, Schaumburg, IL, 60195-1901
Description
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
The product may be contaminated with Burkholderia cepacia
Action
The firm initiated the recall by letter and public notice on 02/18/2021. The letter stated that hazard and requested the return of the product.
Distribution
US Nationwide distribution.
Quantity
56960 bottles