• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

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.

Carrington Labs Issued a Voluntary Recall of Medline Labeled Alcohol-Free Mouthwash -- as a Result, Medline Industries, Inc. is Issuing a Voluntary Nationwide Recall of Personal Hygiene Kits Containing the Same Alcohol- Free Mouthwash Manufactured by Carrington Labs

Contact:
Medline Industries
1-800-MEDLINE

FOR IMMEDIATE RELEASE -- Irving, TX -- August 26, 2005 -- Carrington Labs, Irving, TX has issued a voluntary recall of Medline labeled alcohol-free mouthwash. As a result of this recall, Medline Industries, Inc. Mundelein, IL 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 mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in two states associated with the use of the affected mouthwash.

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), 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

Reorder Number

Alcohol-Free Mouthwash, Medline Label, 2 oz.MDS095029
Alcohol-Free Mouthwash, Medline Label, 4 oz.MDS095030

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 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.

For a complete list of admission kits involved, go to www.medline.com or call Medline Industries at 1-800-MEDLINE for details.

Medline Industries, Inc. is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

####

RSS Feed for FDA Recalls Information [what's this?]