Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth dec

FDA recall notice · announced July 11, 2012 · Ultradent Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.

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.

Notes

Distribution: Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Lot/code information: Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
Quantity: 17, 889 cartons
Status: Terminated
Products in this recall event:
- Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The pro (F-1710-2012)
- 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 defen (F-1709-2012)
- Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The prod (F-1708-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.