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News

Cardinal Health issues recall for Hydrox alcohol-free mouthwash

Cardinal Health : 08 May, 2008  (Company News)
A voluntary recall has been issued for an alcohol-free mouthwash manufactured by Hydrox and labelled with the Cardinal Health brand name and covers individual mouthwash bottles as well as 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 in the USA. The Food and Drug Administration (FDA) has been apprised of this action.

The product was distributed to hospitals, medical centres and long-term care facilities nationwide across the USA. 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 hospitalised 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 is for: Alcohol-Free Mouthwash, Cardinal Health Label, 4 oz (Reorder number: 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.
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