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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-55
August 29, 2005

Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Announces Nationwide Recall of Medline Brand of Alcohol-Free Mouthwash and Hygiene Kits Containing Mouthwash Because of Possible Health Risk

The U.S. Food and Drug Administration (FDA) is notifying the public of a nationwide voluntary recall of alcohol-free mouthwash and hygiene kits containing mouthwash distributed by Medline Industries, Inc., Mundelein, Ill. because of the potential contamination with Burkholderia cepacia. Consumers and health care providers who have Medline brand alcohol free mouthwash should stop using the product immediately and check to see if it is being recalled.

“FDA is committed to informing the public about products that may be contaminated and can potentially cause illness”, said Dr. Lester M. Crawford, FDA Commissioner. “Consumers are encouraged to pay close attention to the identifying information for product information associated with this recall.”

Products being recalled can be identified by checking the lot code stamped on the bottom of the bottle. Product lot numbers beginning 0503 through 0508 are affected. Additionally, affected product can be identified by checking for the identification code RA05CRR on the lower portion of back display panel of the product label.

The recall includes the following products:

Description
Reorder Number
Alcohol-Free Mouthwash, Medline Label, 2 oz.MDS095029
Alcohol-Free Mouthwash, Medline Label, 4 oz.MDS095030

The Medline labeled mouthwash packaged in 2 and 4 oz bottles were recently recalled by the manufacturer, Carrington Laboratories, Inc, Irving, Texas. The mouthwash may also be found in certain Medline Personal Hygiene Hospital Admission Kits.

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.

For a complete list of admission kits involved, go to www.medline.com or call Medline Industries at 1-800-950-0128.

B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. B. cepacia poses little medical risk to healthy people. However, 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. Of note, B. cepacia bacteria are often resistant to common antibiotics.

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