8 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code NTO·May 21, 2021
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code EAX·March 23, 2021
BUTLER Clear Dip, 12 bottles/case
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code OCT·January 14, 2022
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.
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code LFD·February 18, 2021
BUTLER Clear Dip, 12 bottles/case
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·March 9, 2022
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·April 21, 2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·June 16, 2021
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.
FDA Enforcement
Class II
·Terminated·Sunstar Americas, Inc.·March 17, 2021