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Class III: unlikely to cause harmTerminated

Ultradent Products Opalescence Treswhite Supreme Peach Patient Recall

Opalescence Treswhite Supreme Peach Patient Kit

Ultradent Products, Inc. · South Jordan, UT

Risk level
Class III
Reported by FDA
Apr 3, 2013
Recall ID
F-1271-2013
Check your lot numberHow we source this data

Summary

Ultradent Products recalled Opalescence Treswhite Supreme Peach Patient starting Mar 8, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-1271-2013 on Apr 3, 2013. Reason: Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05. Status: Terminated.

Why it was recalled

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

Product description

Opalescence Treswhite Supreme Peach Patient Kit

Lot numbers, UPCs & expiration codes

Lot B6LZS, Part number 5705

Where it was sold

USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain

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-1271-2013
Classification
Class III
Status
Terminated
Recall initiated
Mar 8, 2013
FDA report date
Apr 3, 2013
Quantity
104 units
Recall type
Voluntary: Firm initiated
Recalling firm
Ultradent Products, Inc.

Original FDA data

Every field from FDA enforcement report F-1271-2013, exactly as published.

Show all FDA fields
City
South Jordan
State
UT
Status
Terminated
Country
United States
Event ID
64534
Address
505 W 10200 S
Code information
Lot B6LZS, Part number 5705
Postal code
84095-3935
Report date
Apr 3, 2013
Product type
Food
Recall number
F-1271-2013
Classification
Class III
Recalling firm
Ultradent Products, Inc.
Product quantity
104 units
Termination date
Jul 9, 2013
Reason for recall
Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Opalescence Treswhite Supreme Peach Patient Kit
Distribution pattern
USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain
Recall initiation date
Mar 8, 2013
Initial firm notification
Letter
Center classification date
Mar 26, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1271-2013, published Apr 3, 2013. View the source record (openFDA) · FDA enforcement reports

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

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