Recalled by Ultradent Products, Inc. · South Jordan, UT, United States
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Undeclared allergen: Soy
For someone with a food allergy the label is the only protection. An undeclared allergen can trigger a severe reaction even in a trace amount, which is why most of these recalls are Class I. All undeclared allergens recalls.
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.
Quantity: 4,083 units
Food: Spices & seasonings
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
Georgia
FDA's distribution note: Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Check the codes, then return or discard. Class II means eating it may cause temporary or reversible health problems. If your package matches the recalled codes, do not eat it - return it to the store or throw it away. The risk from an undeclared allergen is to people allergic to soy; for anyone else the product is generally not a safety concern. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
FDA files each product of one recall action separately; these share the same FDA event.
Reason 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…
Reason 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…
Reason Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.
Reason Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but there are no eggs in the product.
Reason Salmonella. The firm received a positive test result of Salmonella in the product.
Reason Potential contamination with Salmonella.
Reason Product tested positive for undeclared milk allergen.