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The Food and Drug Administration (FDA) Announces Voluntary Recall of Alcohol-Free Mouthwash Made by Carrington Labs

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Carrington Labs of Irving, Texas, has issued a voluntary recall of Medline labeled alcohol-free mouthwash. As a result of this recall, Medline Industries, Inc. Mundelein, Illinois, is initiating a voluntary recall of Personal Hygiene Admission kits containing the same alcohol-free mouthwash.

The FDA has been apprised of this action.

The recall includes Alcohol-Free Mouthwash, Medline Label, 2 oz. reorder number MDS095029 and Alcohol-Free Mouthwash, Medline Label, and 4 oz. reorder number MDS095030. The product was distributed to hospitals, medical centers, and long-term care facilities nationwide.

The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The Centers for Disease Control and Prevention (CDC) has confirmed hospital illnesses in two states associated with the use of the affected mouthwash.

B. cepacia poses little medical risk to healthy people. However, people with certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), 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.

Product lot numbers beginning 0503 through 0508 are affected. Affected product can be identified by checking the lot code stamped on the bottom of the bottle.

Additionally, affected product can be identified by checking for the identification code RA05CRR on the lower portion of back display panel of the product label.

The mouthwash may also be found packed in certain Medline Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Medline Industries, Inc. from your healthcare provider please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number(s).

Customers who have Medline labeled alcohol free mouthwash which is being recalled should stop using the product and contact Medline Industries, Inc. for instructions.

Medline Industries, Inc. is notifying their customers via overnight mail and is arranging for all products to be returned for credit. For a complete list of admission kits involved, go to www.medline.com or call Medline Industries at 1-800-MEDLINE for details.

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