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SalivaMAX

Forward Science Technologies LLC · Model SalivaMAX 30ct – 04 NDC · UDI-DI 00370275629047

LFD Prescription

510(k) clearances

411

Adverse events (18 deaths)

Recalls

Facilities

Description

SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis.

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.