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Xerostom® Saliva Substitute Gel

BIO COSMETICS SL · Model Tube 25ml · UDI-DI 08426181972769

LFD

510(k) clearances

411

Adverse events (18 deaths)

Recalls

Facilities

Description

XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth

Recalls

Date	Firm	Reason
2025-06-11	RECORDATI RARE DISEASES INC.	Out of specification stability test result for the Caphosol B solution from process validation lots
2021-02-18	Sunstar Americas, Inc.	The product may be contaminated with Burkholderia cepacia
2013-10-17	GlaxoSmithKline, LLC.	Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
2007-01-19	Gebauer Company	Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
2005-04-22	Kingswood Laboratories,Inc	Contaminated with Aspergillus and Penicillum molds.
2004-02-23	Gebauer Co	The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.