DEERFIELD, Ill., Feb. 28 /PRNewswire-FirstCall/ -- 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 un
|SOURCE Baxter International Inc.|
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