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
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.
Lot numbers, UPCs & expiration codes
Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
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-1709-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 18, 2012
- FDA report date
- Jul 11, 2012
- Quantity
- 4,083 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultradent Products, Inc.
Original FDA data
Every field from FDA enforcement report F-1709-2012, 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: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
- Postal code
- 84095-3935
- Report date
- Jul 11, 2012
- Product type
- Food
- Recall number
- F-1709-2012
- Classification
- Class II
- Recalling firm
- Ultradent Products, Inc.
- Product quantity
- 4,083 units
- 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
- 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.
- 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