Hydrox Inc., Cardinal Health Issue Nationwide Recall of Alcohol-Free Mouthwash For Hospitals

DUBLIN, Ohio -- A voluntary recall has been issued for an alcohol-free mouthwash manufactured by Hydrox, Inc. and labeled with the Cardinal Health brand name. Hydrox and Cardinal Health have initiated the voluntary recall of individual mouthwash bottles and those contained within Cardinal Health Presource(R) kits.

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

The product was distributed to hospitals, medical centers and long-term care facilities nationwide. The product is not sold in retail stores.

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, 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.

The recall includes the following products:

Description                                             Reorder Number

Alcohol-Free Mouthwash, Cardinal Health Label, 4 oz     AG-210

Product lot 26228 is affected. Affected product can be identified by

checking the lot code stamped on the bottom left side of the label.

Patients who have received Cardinal Health branded alcohol-free mouthwash from their healthcare 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.

As the nationwide distributor of this product, Cardinal Health is notifying customers via overnight mail and is arranging for all products to be returned for credit.

Presource customers with alcohol-free mouthwash in their kits should contact the sales operations group toll free at (800) 766-0706. Hospitals that have individual bottles of Cardinal Health labeled alcohol-free mouthwash should contact Cardinal Health Customer Service toll free at (800) 964-5227.

Source: Cardinal Health