The voluntary recall is for mouthwash which had been tested and been found positive for Burkholderia cepacia (B. cepacia)
DUBLIN, Ohio, May 5, 2008 — 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® 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 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.
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.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is an $87 billion, global company serving the health-care industry with products and services that help hospitals, physician offices and pharmacies reduce costs, improve safety, productivity and profitability, and deliver better care to patients. With a focus on making supply chains more efficient, reducing hospital-acquired infections and breaking the cycle of harmful medication errors, Cardinal Health develops market-leading technologies, including Alaris® IV pumps, Pyxis® automated dispensing systems, MedMined™ electronic infection surveillance service, VIASYS® respiratory care products and the CareFusion™ patient identification system. The company also manufactures medical and surgical products and is one of the largest distributors of pharmaceuticals and medical supplies worldwide. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 40,000 people on five continents. More information about the company may be found at www.cardinalhealth.com.
