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Discus Dental LLC recalls Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syri
Recalled December 3, 2014 · FDA recall Z-0425-2015 · Discus Dental
Hazard
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. · FDA Class II
Units
20,251 distributed in U.S. on nationwide level and 14,653 internationally
Sold at
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.
Description
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.
Product
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
Manufacturer(s)
Discus Dental LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →