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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. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html
Urgent Voluntarily Nationwide Recall of DentFresh Fluoride Mint Toothpaste 9 oz (255g)
Dent Fresh U.S.A., Inc.
FOR IMMEDIATE RELEASE -- July 13, 2007 -- 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 allentFresh 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 Central 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 concerned 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 product 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: email@example.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.
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
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