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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1182-2021
Event ID87371
Event DescriptionSUNSTAR 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 TypeDevices
DistributionUS Nationwide distribution.
Quantity56960 bottles
Recall ReasonThe product may be contaminated with Burkholderia cepacia
Device Classification20210317
Device Code InfoAll lot codes within expiry
Center Classification Date20210305
Recall Initiation Date20210218
Recalling FirmSunstar Americas, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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