Baxter Issues Heparin Recall

Baxter International Inc. has issued a voluntary recall for all of its heparin sodium injection products, including single-dose, multidose, and and HEP-LOCK heparin flush products.

The drug, currently under investigation by the Unites States Food and Drug Administration, has been linked to at least four deaths and scores of adverse reactions.

At the Chinese factory where an ingredient for the drug is supplied, U.S. regulators reported “objectionable conditions”.  But a definitive connection to the Chinese plant and the heparin issues has not been made by the FDA to date.

“It’s like trying to put together pieces of a puzzle,” said Sandra Kweder, deputy director of the agency’s Office of New Drugs. “So far, an underlying cause of the adverse events is not known and it remains under investigation.”

“We have assurance from the U.S. 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.”

More details about the recall, including what you should do if you already have the recalled product, can be found at the FDA website.