Baxter recalls all heparin products minus large parenterals

March 4, 2008

Baxter Healthcare Corp. recalls remaining heparin lots.

The Food & Drug Administration has issued a Public Health Update to inform the public that Baxter Healthcare Corp. has extended its recall in addition to heparin sodium injection 5,000 units/ml (10 ml multi-dose vials), 10,000 units/ml (4 ml multi-dose vials), 1,000 USP units/ml (single-dose vials), 5,000 USP units/ml (single-dose vials), 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. The only heparin products from Baxter that will remain on the market are the large-volume parenterals, heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection. The recall was originally issued after an unusually higher number of allergic-like adverse patient reactions were reported. Nearly all the reported reactions have occurred in three specific areas of product use - renal dialysis, invasive cardiovascular procedures, and apheresis procedures. Among the reactions experienced were nausea, vomiting, chest pain, dizziness, fainting, and shortness of breath, including a potentially severe or life-threatening refractory hypotension. Pharmacies should segregate affected lots from their inventory and contact Baxter at 1-(800)-4-BAXTER to arrange for return and replacement product. Pharmacies that purchased the heparin indirectly should contact their wholesaler or distributor for return and replacement.

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