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Recall of DentFresh Fluoride Mint Toothpaste
Release Date: July 18, 2007

NJLINCS Health Alert Network
Public Health Advisory

Distributed by the New Jersey Department of Health and Senior Services

Subject: Voluntary Nationwide Recall of DentFresh Fluoride Mint Toothpaste 9 oz (255 g)
Date: 7/18/2007; 10:28:12
Message #: 100555-7-18-2007-PHAD
Contact Info:   Alan L. Talarsky, NJDHSS/CEHS/Food and Drug Safety Program
Phone: 609-588-3123; Email: at2@njlincs.net
Attachments: None

Please review the following message from Alan Talarsky, Environmental Scientist 1, Food and Drug Safety Program, DHSS regarding the U.S. Food and Drug Administ ration's urgent voluntary recall of DentFresh Fluoride Mint Toothpaste 9 oz (255g).

Dent Fresh U.S.A., Inc, Miami, Florida, is initiating a nationwide recall in accordance with the U.S. Food and Drug Administration (FDA) of the toothpaste made in China involving all DentFresh Fluoride Mint Toothpaste 9 Oz (255g).

This recall has been initiated because the products may contain the poisonous chemical diethylene glycol (DEG). DEG is used in antifreeze and as a solvent, and is a Centr al Nervous System depressant and potent kidney and liver toxin.

FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and 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 concern ed about unintentional swallowing or ingestion of toothpaste containing DEG.

PLEASE RETURN ALL PRODUCTS IMMEDIATELY TO THE STORES WHICH YOU PURCHASED THEM.

CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING AND THEN RETURN TO THE STORE OF PURCHASE OR THROW AWAY.

Retailers immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this prod uct recall. Your notification to your customers may be enhanced by including a copy of this recall notification.

This voluntarily nationwide recall is being made with the knowledge of the U.S. Food and Drug Administration. No injuries or illnesses have been reported to date in connection with this problem.

Consumers with questions may contact the company at: denfresh@hotmail.com or at 305-677-9938.
Adverse Reactions or quality problems experience 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

As with previous recalls of toothpaste containing DEG, the Food and Drug Safety Program recommends that local health departments investigate "dollar stor es" and other low-cost bargain establishments in their jurisdictions to determine if the products have been removed from the shelves. If products are found, we recommend that they be voluntarily destroyed when feasible.

For more detailed information on the toothpaste recall, go to the FDA website at:

http://www.fda.gov/oc/opacom/hottopics/toothpaste.html.

If you have or find information as to where the products have been purchased, please contact either Alan Talarsky or Virginia Wheatley, Food and Drug Safety Program, at (609)588-3123 or via email at alan.talarsky@doh.state.nj.us or virginia.wheatley@doh.state.nj.us.

**********************************************************************************

For more detailed information on the toothpaste recall, go to the FDA website at:

http://www.fda.gov/oc/opacom/hottopics/toothpaste.html.

For all food and drug recalls, go to the FDA website at:

http://www.fda.gov/opacom/7alert s.html






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