Terminated Class II

Ultradent Products, Inc.

Recall F-1710-2012 · South Jordan, UT

Product

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 product is advertised for use in fighting against tooth decay. Part number 8418.

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. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.

Distribution

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

Quantity affected

668 units

Recall type

Voluntary: Firm initiated

Lot / code info

Lot numbers: B6Y7B.

Timeline

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

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