FDA reports voluntary recall of oral care gel
December 18, 2014
Silver Spring, Md.—The U.S. Food and Drug Administration released an Enforcement Report Dec. 2 for Relief ACP Oral Care Gel after its manufacturer voluntarily recalled the product due to an error rendering the gel ineffective or causing it to increase sensitivity.
The Enforcement Report is a listing of all recalls that the FDA monitors.
Discus Dental LLC, which Philips Oral Healthcare acquired in 2010, recalled Relief ACP Oral Care Gel, which dentists prescribe to relieve patient discomfort from dentin sensitivity.
“Philips’ Oral Healthcare brand, Discus Dental, has identified a quality issue with a batch of whitening and oral care gels products produced between March 24, 2014, and May 2, 2014,” said Heather Salvatore, a company spokeswoman. “The affected batch of whitening gels and oral care gels do not deliver the desired result to consumers, due to an incorrect composition of ingredients. There is no anticipated serious risk to the health of users of the affected product. Discus Dental is committed to the highest quality standards and will voluntarily replace these products.”
The product is sold separately as a single syringe, in four or six packs and in teeth whitening kits. The manufacturing error involves products sold after April 1 that were inadvertently filled with hydrogen peroxide teeth whitening gel on one side of the dual barrel syringe instead of phosphate gel.
For more information on the recall, including specific SKU and lot numbers, visit the FDA’s website to view the Enforcement Report for Relief ACP Oral Care Gel.