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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.

 

 

MainStar America, LLC Issues Urgent Voluntary Nationwide Recall of Toothpaste

 

 

Contact:
Mr. Ernesto H. Botta
(305) 637-1127

 

 

FOR IMMEDIATE RELEASE -- Miami, FL -- June 13, 2007 – MainStar America, LLC, 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:

  • Lot #20060708 – Item # 160-850 Dr. Cool Toothpaste 120 GR./4 OZ.
    UPC # 6926597170008
  • Lot #20060708 – Item # 160-852 Superdent Toothpaste 120 GR./4 OZ
    UPC # 6926597170015
  • Lot #20060708 – Item # 160-860 Everfresh Smile2 Toothpaste 25 GR./ 1 OZ.
    UPC # 6926597089539

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.

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

CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING/ RETURN / 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.

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

 

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