Food recall

Ultradent Products, Inc. recall: Cinnamon Xylishield xylitol gum

Ultradent Products, Inc., of South Jordan, UT, recalled Cinnamon Xylishield xylitol gum and 2 other products. The FDA's 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...” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on June 18, 2012, and the FDA first listed it in its Enforcement Report of July 11, 2012. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Metal, plastic, glass or other objects

Status

Terminated

Closed January 9, 2013

The recall

Company
Ultradent Products, Inc. (South Jordan, UT)
Reason, in FDA's words
“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.”
Where it was sold
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
62057

The 3 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1708-2012 Class II

    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.

    Codes: Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.

    Quantity: 17, 889 cartons

  • F-1709-2012 Class II

    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.

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

    Quantity: 4,083 units

  • F-1710-2012 Class II

    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.

    Codes: Lot numbers: B6Y7B.

    Quantity: 668 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of July 11, 2012.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.