Hydrox Labs in Elgin, Illinois has issued a voluntary recall of Cardinal Health-labeled alcohol-free mouthwash due to contamination with Burkholderia cepacia (B. cepacia). As a result of this action, Cardinal Health is also initiating a voluntary recall of the same Cardinal-labeled alcohol-free mouthwash. The US Food and Drug Administration (FDA) has been made aware of this mouthwash recall and the Centers for Disease Control and Prevention (CDC) have confirmed hospital illnesses in one state associated with the use of the Cardinal Health Alcohol-Free Mouthwash. Cardinal Health Alcohol-Free Mouthwash was distributed to hospitals, medical centers, and long-term care facilities nationwide.
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 and B. cepacia bacteria are often resistant to common antibiotics. Treatment occurs on an individualized, one-on-one basis to determine the appropriate antibiotic course of action. The effects of B. cepacia vary widely and range from no symptoms to serious respiratory infections, especially in patients with CF. B. cepacia is the name for a group or “complex” of bacteria that can be found in soil and water and transmission of B. cepacia from contaminated medicines and devices has been reported.
In 2005, the CDC was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash and in 2004, the CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex. Also in 2004, B. cepacia was attributed to nosocomial infections among ICU patients and associated with exposure to sublingual probes.
B. cepacia can also be spread to susceptible persons by person-to-person contact, contact with contaminated surfaces, and exposure to B. cepacia in the environment. Careful attention to infection control procedures like hand hygiene can help reduce the risk of transmission of this organism.
This week’s recall is for Alcohol-Free Mouthwash, Cardinal Health, Reorder number: AG-210. The mouthwash comes in four-ounce bottles and product lot number 26228 is affected. The recalled product can be identified by checking the lot code, which is stamped on the Cardinal Health label; the lot number is located on the side of the bottle.
Cardinal Health Alcohol-Free Mouthwash may also be found in certain Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Cardinal Health with the affected lot number, do not use or immediately stop using the Cardinal Health Alcohol-Free Mouthwash and contact Cardinal Health for instructions: 800-292-9332
Cardinal Health is notifying their customers via overnight mail and is arranging for product returns and credits.
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