Terminated Class II

Ultradent Products, Inc.

Recall F-1709-2012 · South Jordan, UT

Product

Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.

Reason for recall

Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement.

Distribution

Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.

Quantity affected

4,083 units

Recall type

Voluntary: Firm initiated

Lot / code info

Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.

Timeline

18 Jun 2012 initiated 2 Jul 2012 classified 11 Jul 2012 reported 9 Jan 2013 terminated

Sourced directly from the FDA’s openFDA enforcement database. This information is for educational purposes only and does not constitute health or legal advice. FoodRecallFinder.com is not affiliated with or endorsed by the U.S. Food and Drug Administration.