Sunstar G.U.M. Hydral Dry Mouth Spray Recalled for Bacterial Contamination
Sunstar Americas is recalling 56,960 bottles of G.U.M. Hydral Dry Mouth Relief Oral Spray due to potential Burkholderia cepacia contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) without reported illness, which aligns with the 'High' severity criteria for high-risk pathogens without reported illness.
Plain-English summary
Sunstar Americas, Inc. is recalling 56,960 bottles of SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. The product was distributed nationwide in the United States. The recall is being conducted because the product may be contaminated with Burkholderia cepacia.
The affected product is identified by the UPC 0 70942 30713 0. The recall includes all lot codes within the expiration date. The device is formulated with water, moisturizers, sweeteners, and flavors intended to relieve and manage symptoms of dry mouth.
Consumers who have purchased this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but the recall is active for all units matching the description above.
The recalled product
- 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, mo
- Manufacturer
- Sunstar Americas, Inc.
- Category
- Medical Device — Oral Care
- Hazard
- Affected units
- 56,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes within expiry
Distribution
Distributed nationwide across the United States.
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