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Baxter recalls remaining lots and doses of heparin sodium vials
Physicians in possession of these products should discontinue use.
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Baxter Healthcare Corporation announced a voluntary recall of its remaining batch of heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products on Thursday, according to a press release.
The Feb. 28 decision comes just weeks after Baxter stopped manufacturing its multi-dose vials of heparin, as announced on Feb. 11. At that time, the FDA also urged physicians to use an alternate source of anticoagulants.
Baxter recalled nine lots of heparin sodium injection multi-dose vials on Jan. 17, 2008 after a flurry of adverse events were reported. The FDA did not require a recall on all of the company’s heparin multi-dose products at the time due to a lack of suppliers. Now, the FDA says there is sufficient capacity among other suppliers, which allows Baxter to back down without endangering the healthcare industry’s access to the drug.
While the adverse events occurred mostly with the multi-dose products, the company has decided to recall all of its heparin products, excluding heparin pre-mix intravenous solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection, according to the press release.
Precautionary measures
Physicians in possession of the recalled products should discontinue use and segregate the product from existing inventory. Customers should contact Baxter and its wholesale distributors to arrange a return and replacement of the recalled product, according to the press release.
Most adverse reactions have occurred in specific areas of product use, including renal dialysis, invasive cardiovascular procedures and apheresis procedures, though the underlying cause of adverse events remains unknown. Physicians should be aware of profound and refractory hypotension, stomach pain, vomiting, chest pain, shortness of breath and other symptoms, as they may be severe or life-threatening. – by Stacey L. Adams
Customers with questions should call the Center for One Baxter at 1-800-422-9837.