Baxter International Inc., in conjunction with the FDA, is recalling all remaining lots and doses of heparin sodium vial products, including all multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company recently recalled nine lots of the heparin sodium injection multi-dose vials as a precaution due to more than normal reports of adverse reactions from the product. Production was suspended earlier in February.
Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter 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. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. 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 this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.
Even though most consumers who experienced adverse side effects took the multi-dose products, Baxter wants to make sure that consumers are safe and is now recalling all remaining heparin sodium injection and heparin flush products that are still being sold.
In addition to the 100 units/mL, 10 mL, and 30 mL multi-dose vials that were already recalled, the company is adding the following:
the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, 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.
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.
Almost all adverse side effects reported by consumers have involved three specific areas of the product’s use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. To see a list of adverse side effects click here. Consumers have been advised to stop using these recalled products and segregate the product for the rest of its inventory.