Baxter to Proceed With Recall of Remaining Heparin Sodium Vial Products

DEERFIELD, Ill., Feb. 28 - Baxter International
Inc. announced today that the company is proceeding with the voluntary
recall of all remaining lots and doses of its heparin sodium injection
multi-dose, single-dose vials and HEP-LOCK heparin flush products.

    The company initially recalled nine lots of heparin sodium injection
multi-dose vials on January 17, 2008 as a precautionary measure due to a
higher than usual number of reports of adverse patient reactions involving
the product and suspended production earlier this month.

    Given the widespread use of this blood thinner and the impact a product
shortage would have on operating rooms, dialysis centers and other critical
care areas, the FDA and Baxter concluded that removing additional lots and
doses of Baxter’s heparin from the market earlier would have created more
risk to patients requiring heparin therapy than the increased potential for
experiencing an adverse reaction. Accordingly, the FDA and Baxter decided
not to recall all Baxter heparin vial products at that time. The FDA has
now concluded that there is sufficient capacity on the part of other
suppliers that Baxter’s recall will not jeopardize access to this drug, and
has told Baxter that the company can now proceed with recalling its
remaining heparin sodium injection and heparin flush products.

    Although the vast majority of the reports of adverse reactions have
been associated with the multi-dose products, Baxter is taking the
precautionary step of recalling all remaining heparin sodium injection and
heparin flush products that are currently on the market. In addition to the
previously recalled lots of heparin sodium injection 1000 units/mL 10mL and
30mL multi- dose vials, Baxter’s recall will now include the remaining lots
of those products and heparin sodium injection 5000 units/mL 10mL
multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose
vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and
10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P,
10 USP units/mL and 100 USP units/mL vials, both preserved and
preservative-free.

    This recall does not involve Baxter’s heparin pre-mix IV solutions in
bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9%
sodium chloride injection.

    “We have assurance from the U.S. Food and Drug Administration that
there is an adequate supply in the market to meet the demand for these
critical and lifesaving drugs,” said Peter J. Arduini, president of
Baxter’s Medication Delivery business. “The safety and quality of our
products is always our highest priority, and we will continue to
collaborate with the FDA as we work to determine the cause of the increased
rate of adverse reactions and resolve this issue.”

    Nearly all reported adverse reactions have occurred in three specific
areas of product use — renal dialysis, invasive cardiovascular procedures
and apheresis procedures. Reported adverse patient reactions have included:
stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low
blood pressure, chest pain, fast heart rate, dizziness, fainting,
unresponsiveness, shortness of breath, the feeling of a strong or rapid
heartbeat, drug ineffectiveness, burning sensation, redness or paleness of
skin, abnormal sensation of the skin, mouth or lips, flushing, increased
sweating, decreased skin sensitivity, headache, feeling unwell,
restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and
difficulty opening the mouth. Some of these reactions, particularly
profound and refractory hypotension, may be severe or life-threatening.

    Customers have been instructed to discontinue use and segregate the
recalled product from the rest of their inventory. Customers should then
contact Baxter to arrange for return and replacement product. Customers
with recalled product purchased indirectly should contact their wholesaler
or distributor for return and replacement product. Customers with questions
may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837).
Representatives will be available twenty-four hours a day, seven days a
week.

    Baxter International Inc. (NYSE: BAX), through its subsidiaries,
assists healthcare professionals and their patients with the treatment of
complex medical conditions, including cancer, hemophilia, immune disorders,
kidney disease and trauma. The company applies its expertise in medical
devices, pharmaceuticals and biotechnology to make a meaningful difference
in patients’ lives. For more information about Baxter, visit
http://www.baxter.com.

SOURCE Baxter International Inc.