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Moisyn Dry Mouth Oral Rinse
SYNEDGEN, INC. · Model 300mL · UDI-DI 00852181005097
1
510(k) clearances
411
Adverse events (18 deaths)
6
Recalls
40
Facilities
Description
Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate
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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