Baxter International 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 vials on January 17, 2008 as a precaution due to reports of adverse patient reactions and suspended production earlier this month.
The FDA and Baxter held off on recalling all lots of the drug at once to avoid a product shortage, which would impact operating rooms, dialysis centers and other critical care areas. The FDA has concluded that there is now sufficient capacity on the part of other suppliers to provide access to the drug, and has told Baxter that it can now proceed with recalling its remaining heparin products.
Although most of the reports of adverse reactions have been associated with the multi-dose products, Baxter is recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. 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 FDA 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."
Customers have been instructed to discontinue use and to contact Baxter to arrange for return and replacement product.
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