Health

Advisory

NOSOCOMIAL BURKHOLDERIA CEPACIA PNEUMONIA ASSOCIATED WITH CONTAMINATED ALCOHOL-FREE MOUTHWASH

This message is being relayed by the Delaware Division of Public Health (DPH). To contact the DPH about this Health Advisory,

call 1-888-295-5156. This number is answered during normal business hours, and during non-business hours for emergencies.

This is an official

CDC Health Advisory

Distributed via Health Alert Network

August 26, 2005, 18:00 EDT (06:00 PM EDT)

CDCHAN-00230-05-08-26-ADV-N

Nosocomial Burkholderia Cepacia Pneumonia Associated With

Contaminated Alcohol-Free Mouthwash

The Centers for Disease Control and Prevention (CDC) has been notified by several states of clusters of pneumonia and other infections

caused by Burkholderia cepacia. These cases had exposure to alcohol-free mouthwash manufactured by Carrington Labs (Irving, TX) for

Medline Industries (Mundelein, IL). Cultures performed by a hospital laboratory where the first cases were detected indicate that

multiple lots of Medline alcohol-free mouthwash are intrinsically contaminated with B. cepacia. In August 2005, the Texas Department of

State Health Services was notified of a cluster of nosocomial pneumonia involving three patients hospitalized at a Texas health-care

facility.

All three patients were intubated and in the intensive care unit for their underlying illnesses when they developed signs of pneumonia

and respiratory cultures grew B. cepacia. All three patients had received oral care using 4 oz. bottles of Medline alcohol-free mouthwash

prior to illness onset. One patient has recovered and has been discharged. The second and third remain hospitalized, one with a poor

prognosis. Molecular typing is pending. An additional two clusters (2 cases and 5 cases), both associated with prior use of Medline

alcohol-free mouthwash, are currently being investigated in two Florida health-care facilities.

CDC is working with state health departments and the Food and Drug Administration to determine the magnitude of this outbreak. Carrington

Labs analysis of in-house retain samples has confirmed contamination in multiple lots of the product in both 4 oz. and 2 oz. bottles

leading to a recall of all alcohol-free mouthwash manufactured by Carrington Labs for Medline.

The suspect product bears a 7 or 8 digit lot number on the bottom of the bottle; suspect lot numbers include numbers 0503*** through

0508*** and 0503**** through 0508**** (asterisks represent any digit). The product is available in 2 oz. bottles as well as 4 oz. bottles

and was distributed only to hospitals and long term care facilities. The product is not distributed for direct retail sale to the

consumer. However, the 2 oz. bottles are packaged with other items, such as toothbrushes, toothpaste, etc. by Medline into a

‘personal hygiene hospital admission kit’ so some mouthwash may be in the possession of the consumer within a residential

setting. Medline alcohol-free mouthwash with the above lot numbers should not be used. Individuals who are aware of cases of B. cepacia

colonization or infection occurring during or shortly after exposure to these products should contact their health department and CDC at

1-800-893-0485.