Reported Dec 3, 2014 · Terminated
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single…
Discus Dental LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Discus Dental LLC · 1700 S Baker Ave Ste A · Ontario, CA · 91761-8081
Is this the product you have?
- 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
- Lot codes and dates
- - 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 NumberList of Teeth Whitening kits containing Relief ACP Oral Care Gel products distributed outside of U.S.: SKU Number Lot Number
ZM266514090044ZM266514097026ZM266514104024ZM266514106004ZM266514113035ZM266514121018ZM266514122005ZM266514134020ZM266614104025ZM266614105025ZM266614113028ZM266614118015ZM266614127019ZM266614134030ZM266614139005DSH100114113006DHS100114127007
ZME266514143017ZME266514143024ZME263114132015ZME2645R14153007ZME266714147003ZME266714132016ZME266714141020ZME266714143009ZME266714164002ZME2667141690088810567015311413501688105700153114135007
- - 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
- Amount recalled
- 20,251 distributed in U.S. on nationwide level and 14,653 internationally
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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