The Recall Desk

FDA (Food) recall action 62057

Ultradent Products, Inc. recalled 3 products on 2012-07-11

The FDA (Food) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-07-11
Critical
0
Units
4,751

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Food)··2012-07-11

    Ultradent Recalls Xylishield Gum for Missing Soy Allergen Labeling

    Ultradent is recalling specific lots of Xylishield gum because the packaging failed to list soy as an ingredient. A separate lot of spearmint gum was also recalled due to accidental cinnamon flavoring.

    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.
    Category
    Distribution
    1 state
  • HighFDA (Food)··2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of Cinnamon Xylishield gum because the packaging fails to list soy as an ingredient. The gum was distributed globally.

    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.
    Category
    Distribution
    1 state
  • HighFDA (Food)··2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.

    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.
    Category
    Distribution
    1 state