Food recall

Ultradent Products, Inc. recall: Opalescence Treswhite Supreme Peach Patient Kit

Ultradent Products, Inc., of South Jordan, UT, recalled Opalescence Treswhite Supreme Peach Patient Kit. The FDA's reason: “Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on March 8, 2013, and the FDA first listed it in its Enforcement Report of April 3, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed July 9, 2013

The recall

Company
Ultradent Products, Inc. (South Jordan, UT)
Reason, in FDA's words
“Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.”
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
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
64534

The product recalled

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

  • F-1271-2013 Class III

    Opalescence Treswhite Supreme Peach Patient Kit

    Codes: Lot B6LZS, Part number 5705

    Quantity: 104 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 April 3, 2013.

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.