Tainted Heparin ingredients came from troubled plant in China

WASHINGTON — A recalled blood thinner made with active ingredients from China appears to have been contaminated by a mysterious look-alike substance, now the focus of an investigation into as many as 19 U.S. deaths and nearly 800 serious drug reactions, federal officials said Wednesday.

The drug — heparin — is a generic medication given to patients undergoing heart surgery or kidney dialysis to prevent dangerous blood clots. The manufacturer, Illinois-based Baxter Healthcare, issued recalls last month after it noticed an unusual spike in reports of severe side effects.

The Food and Drug Administration's findings raised questions about whether the medication was contaminated deliberately or whether some problem occurred in processing, either in China or in the United States.

FDA officials said the as-yet unidentified contaminant was detected only through sophisticated testing not generally done by manufacturers or their suppliers. In the kinds of routine tests required before the drug was shipped, the contaminant apparently behaved much like heparin, and its presence went unnoticed.

"This substance ... appears to act like heparin," said FDA deputy commissioner Janet Woodcock, calling the case "a classic chemical investigation."

The agency has come under fire from Congress because it failed to inspect the Chinese facility, Changzhou SPL, that produced the heparin before allowing it to ship the drug to the United States. Someone at the FDA mixed up the name of the plant with that of another facility that had been inspected.

A belated FDA inspection last month found a series of problems with documentation, equipment and waste disposal at the Changzhou plant.