 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
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.
Contact:
Cindy Duran, Borshoff Johnson Matthews
(317)
631-6400, ext. 237
FOR IMMEDIATE RELEASE -- Indianapolis, IN -- August 13, 2007 -- Gilchrist & Soames, an Indianapolis-based provider of toiletry products for the hotel industry, has initiated a worldwide voluntary recall of its Gilchrist & Soames 0.65oz/18ml toothpaste manufactured in China for the company by Ming Fai Enterprises International Co., LTD, after independent tests showed some samples of the toothpaste contained diethylene glycol, or DEG.
The United States Food and Drug Administration ("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. This voluntary recall is being conducted in cooperation with the FDA. The Company also has notified the Department for Business, Enterprise and Regulatory Reform in the UK to enable it to notify the European Commission to launch a RAPEX notification in the European Union.
Hotels in the United States, Canada, Mexico, Bermuda, Barbados, Dominican Republic or Turks & Caicos that received the recalled toothpaste from the company’s United States distribution center, and those located in the U.K., Ireland, Spain, Belgium, France, Italy, Germany, Switzerland and the UAE serviced by the company’s U.K. distribution center, are being asked to destroy any remaining inventory.
Hotel guests, who may have received the recalled toothpaste from hotels in any of these countries, should safely dispose of it.
"After receiving the FDA alert June 1 about tainted toothpaste manufactured in China, we immediately contacted our two Chinese toothpaste suppliers and initiated a series of independent lab tests in both Hong Kong and the United States to determine the possible presence of DEG," said Kathie De Voe, president of Gilchrist & Soames.
At the same time, Gilchrist & Soames stopped all outgoing shipments and quarantined all of its "Made in China" toothpaste. The Company also communicated with all of its hotel clients and suggested that they stop offering Chinese-made Gilchrist & Soames toothpaste to their guests until further investigation and independent testing by Gilchrist & Soames and the FDA. The June 1 FDA Consumer Alert was attached. The Company took these steps even though its toothpaste was not among those cited in the FDA warning.
De Voe said, "The fifth round of our independent lab tests showed the presence of DEG in some samples at levels exceeding FDA guidelines from one of our China suppliers. We immediately began the process of initiating a voluntary recall of our complimentary-sized (.65oz/18ml) Gilchrist & Soames toothpaste. We want to ensure that any contaminated toothpaste is safely disposed of and/or destroyed."
Gilchrist & Soames is notifying its hotel clients in those countries where the toothpaste was distributed to discard their inventories. The Company is working with each hotel on a guest notification program. Materials will inform guests about this voluntary recall, including the FDA Web address for current toothpaste recalls (http://www.fda.gov/oc/opacom/hottopics/toothpaste.html), as well as a toll-free telephone number at Gilchrist & Soames U.S. headquarters (1-866-587-6542) that hotel guests may call if they desire more information about the recall. The European Union Web address for further information about toothpaste manufactured in China is http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm. Local contact numbers in Europe for Gilchrist & Soames are as follows: Germany – 004908000004988, Ireland – 00353 1800932251, France – 0033 0805114958, Spain – 0034800098797, Switzerland - 0041 0800 001285, Hungary – 0036 0680018077, Italy – 0039 800986779, UK – 08003112139, Belgium – 0032 080048630.
De Voe said, "We are thankful that the small size of our tubes (.65oz/18ml) may help reduce the risk. However, we strongly encourage consumers to dispose of any of the recalled toothpaste they may still have."
Gilchrist & Soames is working with its global supply chain partners to be certain they meet the standards and specifications outlined in its new testing criteria. New testing to confirm the absence of DEG will be part of that process. This recall is being conducted with the knowledge of the FDA, and the European Authorities.
####
RSS Feed for FDA Recalls Information [what's this?]
Get free e-mail alerts about Class I recalls