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U.S. Department of Health and Human Services

Safety

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Alcohol-Free Mouthwash and Hygiene Kits by Medline

Audience: Risk managers and hospital and long term care nursing supervisory staff

[Posted 08/29/2005] Medline and FDA notified healthcare professionals about a nationwide recall of Alcohol-Free Mouthwash and Hygiene Kits containing mouthwash because of potential contamination with Burkholderia cepacia. People who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. The product was distributed to hospitals, medical centers, and long term care facilities nationwide. There is no known distribution through retail sales. The CDC has confirmed hospital illness associated with the use of the affected mouthwash in Texas and Florida.

[August 29, 2005 - Notice - FDA]
[August 29, 2005 - Firm Press Release - Medline]