Recall Z-1182-2021 · LFD Saliva, Artificial
Sunstar Americas, Inc.
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.
| Date | Feb 18, 2021 |
| Status | Terminated |
| Reason | The product may be contaminated with Burkholderia cepacia |
| Root cause | Process control |
| 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. |
| Quantity | 56960 bottles |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181134 | GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray Sunstar Americas, Inc., Jul 13, 2018 |