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Alcohol-Free Mouthwash Recalled

May 8, 2008
Cardinal Health, Inc., has recalled its alcohol-free mouthwash manufactured by Hydrox, Inc. and marketed mostly to health care facilities. Both individual mouthwash bottles and those contained within Cardinal Health Presource kits are included in the voluntary recall.

The company says the mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The Centers for Disease Control and Prevention has confirmed the use of the affected mouthwash is associated with hospital illnesses in one state. The Food and Drug Administration has been apprised of this action, the company said.

The product is not sold in retail stores.

The company said B. cepacia poses little medical risk to healthy people, but 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 B. cepacia. B cepacia is a known cause of infections in hospitalized patients.

B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.

Affected product can be identified by checking the lot code stamped on the bottom left side of the label. Product lot 26228 is affected

Patients who have received Cardinal Health branded alcohol-free mouthwash from their health care provider are advised to check the reorder number and lot number on the label. Patients who have mouthwash with a reorder number of AG-210 and lot number of 26228 should stop using the product immediately.

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