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Class II: temporary or reversible health riskTerminated

Ultradent Products Cinnamon Xylishield xylitol gum Recall

Cinnamon Xylishield xylitol gum

Ultradent Products, Inc. · South Jordan, UT

Risk level
Class II
Reported by FDA
Jul 11, 2012
Recall ID
F-1708-2012
Check your lot numberHow we source this data

Summary

Ultradent Products recalled Cinnamon Xylishield xylitol gum starting Jun 18, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1708-2012 on Jul 11, 2012. 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 sub-ingredient in the ingredients statement. Status: Terminated.

Why it was 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.

Product description

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1708-2012
Classification
Class II
Status
Terminated
Recall initiated
Jun 18, 2012
FDA report date
Jul 11, 2012
Quantity
17, 889 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Ultradent Products, Inc.

Original FDA data

Every field from FDA enforcement report F-1708-2012, exactly as published.

Show all FDA fields
City
South Jordan
State
UT
Status
Terminated
Country
United States
Event ID
62057
Address
505 W 10200 S
Code information
Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
Postal code
84095-3935
Report date
Jul 11, 2012
Product type
Food
Recall number
F-1708-2012
Classification
Class II
Recalling firm
Ultradent Products, Inc.
Product quantity
17, 889 cartons
Termination date
Jan 9, 2013
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Recall initiation date
Jun 18, 2012
Initial firm notification
Letter
Center classification date
Jul 2, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1708-2012, published Jul 11, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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