Baxter expands heparin recall
August 14th, 2008 by Wendi Lewis
In February, Baxter International Inc. announced it would expand its recall of heparin sodium injection products. In January, 2008, the company recalled nine lots of a heparin product as a result of reports of adverse patient reactions. It suspended production of the products in early February.
The new expanded recall includes all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. The recall will not include Baxter’s heparin pre-mix IV solutions in bags.
Although there was a danger of contamination that could result in adverse patient reaction, the U.S. Food & Drug Administration did not require Baxter to do a full recall of the product in January because pulling all of the product could create a shortage for operating rooms, dialysis centers and other critical areas that use the product, which is a blood thinner.
According to a Baxter news release, in January the FDA determined the risk of patients not receiving any heparin blood thinners when it was critically needed was greater than that of patients receiving contaminated product. Baxter is one of the leading suppliers of heparin products, manufacturing about one half of the multidose vials used each month by health care providers.
The FDA now feels there is enough heparin available from other sources to allow Baxter to pull its remaining, possibly contaminated, product.
Customers are advised to immediately discontinue use of recalled product, and to contact Baxter for return and replacement.
Despite FDA assurances that there is enough heparin product in the market to treat critical patient needs, by March health care providers were being more careful with prescribing their existing supplies as a result of the more limited supply.