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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

 

Contact:
Cardinal Health
800-292-9332

 

FOR IMMEDIATE RELEASE -- Elgin, IL -- May 16, 2008 Hydrox Labs, Elgin, IL has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a voluntary sub recall of this lot of alcohol-free mouthwash. The FDA has been apprised of the action. The mouthwash was tested, and certain samples were found positive for Burkholderia cepacia (B. cepacia).

Product was distributed to hospitals, medical centers, and long term care facilities nationwide.

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 (CF) or on mechanical ventilators, 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 CF.

The recall includes the following products:

Description

Cardinal Label Reorder Number

Lot Number

Alcohol-Free Mouthwash, Cardinal Health, 4 oz.AG-21026230

Affected product can be identified by checking the lot number stamped on the Cardinal Health label. The Lot number is located on the side of the bottle.

The mouthwash may be found in certain Personal Hygiene Hospital Admission Kits. If you received Cardinal Health labeled alcohol-free mouthwash from your healthcare provider, please compare the Cardinal Health reorder number on the upper left corner of the product label with the recalled reorder number above, then check to see if the lot number at the bottom of the label matches the recalled lot number.

Customers who have Cardinal Health labeled alcohol free mouthwash being recalled should stop using the product and contact Cardinal Health at the number above for instructions.

Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

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