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FDA MedWatch


05/06/2008 -  Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Cardinal

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