Deerfield, IL - Baxter International is now 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 [1].

This follows the recent increase in adverse reactions seen with the product, which have almost all been seen in three specific areas of product use—renal dialysis, invasive cardiovascular procedures, and apheresis procedures.

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

The company initially recalled nine lots of heparin sodium injection multidose vials in January, and earlier this month it 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 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. But 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. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10-mL and 30-mL multidose vials, Baxter's recall will now include the remaining lots of those products and the following:

• Heparin sodium injection 5000 units/mL 10-mL multidose vials.
• Heparin sodium injection 10 000 units/mL 4-mL multidose vials.
• Heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10 000 USP units/mL single-dose vials.
• All HEP-LOCK and HEP-LOCK U/P 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

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.