| Date Initiated by Firm | February 18, 2021 |
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| Create Date | March 05, 2021 |
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| Recall Status1 |
Terminated 3 on September 30, 2024 |
| Recall Number | Z-1182-2021 |
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| Recall Event ID |
87371 |
| 510(K)Number | K181134 |
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| Product Classification |
Saliva, artificial - Product Code LFD
|
| 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, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth. |
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| Code Information |
All lot codes within expiry |
Recalling Firm/
Manufacturer |
Sunstar Americas, Inc.
301 E Central Rd
Schaumburg IL 60195-1901
|
Manufacturer Reason
for Recall | The product may be contaminated with Burkholderia cepacia |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 56960 bottles |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LFD
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