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Caphosol® Artifical Saliva

EUSA PHARMA (UK) LIMITED · Model 64 x 15 mL sachets aqueous solution · UDI-DI 05060146293129

LFD Prescription

510(k) clearances

411

Adverse events (18 deaths)

Recalls

Facilities

Description

Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.

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.