Baxter Recalls all Remaining Heparin Vial Products

Baxter International (Deerfield, IL, USA) is recalling from the market all remaining lots and doses of its heparin sodium multidose and single-dose vials for injection and its heparin lock flush solutions.

The recall was issued following a recent increase in adverse reactions seen with the product, which have almost all been observed in three specific areas of product use; renal dialysis, invasive cardiovascular procedures, and apheresis procedures. The recall does not involve Baxter's heparin premixed intravenous (IV) solutions in bags, which include a heparin sodium in 5% dextrose injection and a heparin sodium in 0.9% sodium-chloride injection. The company initially recalled nine lots of heparin sodium injection multidose vials in January 2008, and in early February 2008 suspended production. Baxter says that given the widespread use of heparin and the impact a product shortage would have on operating rooms, dialysis centers, and other critical-care areas, the U.S. Food and Drug Administration (FDA) and the company 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. However, 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 heparin, and it 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 multidose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market, that is, in addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10-mL and 30-mL multidose vials. 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.

Heparin, a highly sulfated glycosaminoglycan is widely used as an injectable anticoagulant and has the highest negative charge density of any known biological molecule. Because of its short biologic half-life of approximately one hour, heparin must be given frequently or as a continuous infusion. However, the use of low molecular weight heparin (LMWH) has allowed once daily dosing, thus not requiring a continuous infusion of the drug. If long-term anticoagulation is required, heparin is often used only to commence anticoagulation therapy until the oral anticoagulant warfarin takes effect.


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