Sunstar Americas, Inc. Recall 87371
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.
Sunstar Americas, Inc. Recall 87371 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1182-2021 |
| Event ID | 87371 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 56960 bottles |
| Recall Reason | The product may be contaminated with Burkholderia cepacia |
| Device Classification | 20210317 |
| Device Code Info | All lot codes within expiry |
| Center Classification Date | 20210305 |
| Recall Initiation Date | 20210218 |
| Recalling Firm | Sunstar Americas, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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