Glaxosmithkline
FDA adverse event reports naming Glaxosmithkline as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GLAXOSMITHKLINE.
- Total reports
- 1,286
- Deaths
- 26
- Injuries
- 57
- Malfunctions
- 4
Reports per year
Source: FDA adverse event reports by year received, 2006–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide HomopolymerKOL1,018
- Saliva, ArtificialLFD64
- Cleanser, Denture, Over The CounterEFT52
- Dilator, NasalLWF46
- Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double SaltKOO42
- Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-SodiumKOT30
- Toothbrush, ManualEFW14
- Adhesive, Denture, KarayaKOP12
- Cleaner, Denture, MechanicalJER4
- Product code ------3
Recent recalls
- 2013-11-13TerminatedLabeling Change Control
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
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