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SmartMouth
Triumph Pharmaceuticals Inc. · Model SM.DR480 · UDI-DI 00697366003556
1
510(k) clearances
411
Adverse events (18 deaths)
6
Recalls
40
Facilities
Description
SmartMouth DryMouth Rehydrating Oral Rinse with artificial saliva for use in the oral cavity.
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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Get your free API keyRead the docsData 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.