PRA number
2014/14423
Published date
Product description
Relief ACP Oral Care Gel sold to Dental Practices as part of in chair whitening kits and bulk unit packaging, designed for both in chair use by the dentists on consumers, and to be individually dispensed or sold to consumers following an in chair procedure as a take home product. Relief ACP Oral Care Gel is designed to provide relief after application of whitening product and contains Amorphous Calcium Phosphate. Discus Dental has sold 710 syringes of affected Relief ACP Oral Care Gels in Australia to 54 identified Dental Practices from 4 August 2014.
Reasons the product is recalled
Affected lots of Relief ACP Oral Care Gel 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).
The hazards to consumers
Use of the affected product may result in increased sensitivity.
What consumers should do
Consumers should return the affected product to place of purchase for a replacement product. For any queries, customers should contact their dentists directly or Discus Dental on 1800 621 448.
The Dental Practices with affected products were notified of the recall on 4 November 2014.
The Dental Practices with affected products were notified of the recall on 4 November 2014.
Supplier
Discus Dental Australia Pty Limited
Traders who sold this product
54 identified Dental Practices who provide Discus Dental Whitening products.
Where the product was sold
New South Wales
Queensland
South Australia
Victoria
Western Australia
Dates available for sale
-
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.