Baxter International Inc has announced that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.
The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centres and other critical care areas, the US Food and Drug Administration (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 jeopardise 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.
Although the vast majority of the reports of adverse reactions have been associated with the multi-dose 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 1,000 units/ml 10ml and 30ml multi-dose vials, Baxter’s recall will now include the remaining lots of those products and heparin sodium injection 5,000 units/ml 10ml multi-dose vials, heparin sodium injection 10,000 units/ml 4ml multi-dose vials, heparin sodium injection 1,000 USP units/ml, 5,000 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.
“We have assurance from the US Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” said Peter J. Arduini, president of Baxter’s Medication Delivery business.
“The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue.”