FDA Urges Medical Providers to Double Check Supplies for Recalled Baxter Heparin

On May 9th, the FDA issued another statement to healthcare providers regarding the Baxter heparin recall that was issued on February 11th. Due to concerns that supplies of contaminated heparin may still be in storage, the FDA has urged surgeons, dialysis centers, hospitals and other healthcare providers to make sure that all of the recalled heparin has been removed and is no longer being used.

Heparin is a blood thinner used during cardiac surgery, dialysis and a variety of other medical procedures to reduce the risk of blood clots. Heparin Sodium injections manufactured and sold by Baxter Healthcare Corp. were recalled earlier this year after a number of reported allergic reactions began to surface. That recall called for nearly half the heparin in the United States to be removed from shelves.

Over the past few months, investigations have confirmed that the heparin sold by Baxter was contaminated with a fake chemical known as oversulfated chondroitin sulfate. This was used as a cheap substitute ingredient in raw heparin that was provided to Baxter by a manufacturing plant in China. It is believed that this contaminant is responsible for causing hundreds of allergic reactions and at least 81 deaths in the United States.

Although most of the reported injuries involved people who received multiple or heavy doses of heparin, recalls have also been issued for prefilled heparin syringes and some medical devices coated with the blood thinner. Similar recalls have also been issued in Germany, Japan, Canada and several other countries where raw heparin was manufactured at the same plant in China.

Despite the publicity surrounding the heparin recall, the FDA is concerned that some facilities or hospitals may still be using the contaminated heparin. Facilities have been asked to double check all potential storage areas, including emergency kits, dialysis units, automated drug storage cabinets and any other locations where heparin or devices coated with heparin may be stored.