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Terminated

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 Z-1182-2021 · Posted None

Recalling FirmSunstar Americas, Inc.
Recall StatusTerminated
Product CodeLFD
Date Initiated2021-02-18
Date Terminated2024-09-30
Product Quantity56960 bottles

Reason for Recall

The product may be contaminated with Burkholderia cepacia

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc. · 2018-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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