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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Donnamax Inc. Issues Nationwide Voluntary Recall of Dentapro and Bright Max Brands of Toothpaste

 

Contact:
Raymond Zeitouny
(718) 854-0273

 

FOR IMMEDIATE RELEASE -- Brooklyn, NY -- August 7, 2007 -- Donnamax Inc. of Brooklyn, NY, has initiated a voluntary recall of the following brands of toothpaste made in China:

  • DentaPro brand CAVITY FIGHTING FLUORIDE TOOTHPASTE, FRESH SPEARMINT FLAVOR, NET WT. 6.4 oz. - Item No. 9112, UPC 8 71290 – 00062 5, and
  • Bright Max Toothpaste, NET WT. 6.4 oz. - Item No. 9111

This recall has been initiated because the products may contain diethylene glycol (DEG), also known as “diglycol”.

The FDA is not aware of any U.S. reports of poisoning from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of tooth paste with DEG.

CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING THEM, AND RETURN THEM TO THE PLACE OF PURCHASE, OR THROW THEM AWAY.

The toothpaste products were sold to retail stores located in the states of New York, Pennsylvania, Massachusetts, Michigan, Ohio, Illinois, Mississippi, South Carolina, Georgia, Florida, and Idaho.

No injuries or illnesses have been reported to date in connection with this problem.

Retailers should immediately examine their inventory for the recalled brands of toothpaste, remove them from sale, destroy any units found, and report the quantity destroyed on the response form to Donnamax Inc. as soon as possible.

This voluntarily recall is being made with the knowledge of the U.S. Food and Drug Administration.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax:

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

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