FDAFDA · Alimentos y medicamentos·N.º oficial Z-0425-2015
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Publicado el 3 de diciembre de 2014 · Inicio del retiro: 24 de octubre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Discus Dental LLC
- Distribuidor
- Worldwide distribution including Nationwide (U.S.) and the countries of New Zealand, Australia, Canada, Germany, Switzerland, Italy, Austria, Finland, South Africa, United Arab Emirates, Korea, Turkey, Egypt, Jordan, Thailand, Lebanon, Kuwait, Tunisia, India, and Dominican Republic.
- Lote
- - List of Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number PV1602 14111008 PV1602 14127009 PV1609 14141018 - List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed in U.S. SKU Number Lot Number ZM2665 14090044 ZM2665 14097026 ZM2665 14104024 ZM2665 14106004 ZM2665 14113035 ZM2665 14121018 ZM2665 14122005 ZM2665 14134020 ZM2666 14104025 ZM2666 14105025 ZM2666 14113028 ZM2666 14118015 ZM2666 14127019 ZM2666 14134030 ZM2666 14139005 DSH1001 14113006 DHS1001 14127007 List of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number ZME2665 14143017 ZME2665 14143024 ZME2631 14132015 ZME2645R 14153007 ZME2667 14147003 ZME2667 14132016 ZME2667 14141020 ZME2667 14143009 ZME2667 14164002 ZME2667 14169008 881056701531 14135016 881057001531 14135007
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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