DUBLIN, Ohio, May 5 /PRNewswire-FirstCall/ -- A voluntary recall has
been issued for an alcohol-free mouthwash manufactured by Hydrox, Inc. and
labeled with the Cardinal Health brand name. Hydrox and Cardinal Health
have initiated the voluntary recall of individual mouthwash bottles and
those contained within Cardinal Health Presource(R) 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. The Food and Drug Administration (FDA) has been
apprised of this action.
The product was distributed to hospitals, medical centers and long-term
care facilities nationwide. 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
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 cystic fibrosis.
The recall includes the following products:
Description Reorder Number
Alcohol-Free Mouthwash, Cardinal Health Label, 4 oz 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.
Presource customers with alcohol-free mouthwash in their kits should
contact the sales operations group toll free at (800) 766-0706. Hospitals
that have individual bottles of Cardinal Health labeled alcohol-free
mouthwash should contact Cardinal Health Customer Service toll free at
(800) 964-5227.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is an
$87 billion, global company serving the health-care industry with products
and services that help hospitals, physician offices and pharmacies reduce
costs, improve safety, productivity and profitability, and deliver better
care to patients. With a focus on making supply chains more efficient,
reducing hospital-acquired infections and breaking the cycle of harmful
medication errors, Cardinal Health develops market-leading technologies,
including Alaris(R) IV pumps, Pyxis(R) automated dispensing systems,
MedMined(TM) electronic infection surveillance service, VIASYS(R)
respiratory care products and the CareFusion(TM) patient identification
system. The company also manufactures medical and surgical products and is
one of the largest distributors of pharmaceuticals and medical supplies
worldwide. Ranked No. 19 on the Fortune 500, Cardinal Health employs more
than 40,000 people on five continents. More information about the company
may be found at http://www.cardinalhealth.com .
SOURCE Cardinal Health
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Related links:
http://www.cardinalhealth.com
CONTACT:
Media: Troy Kirkpatrick, +1-614-757-6225,
troy.kirkpatrick@cardinalhealth.com, or Investors: Sally Curley,
+1-614-757-7115, sally.curley@cardinalhealth.com
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