Heparin Is Recalled

The Food and Drug Administration is issuing this update to inform the public that Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.

As a precautionary measure Baxter is also recalling its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.

Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity. With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials. FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.

The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags. No adverse events have been reported in relation to the large volume solution. The heparin source manufacturer for the large volume solution is different from that of the products being recalled.

On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation. A description of the clinical settings and characteristics of the cases of serious adverse events that resulted in the public health advisory can be found at http://www.fda.gov/cder/drug/advisory/heparin.htm.

The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation. FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events.

FDA continues to monitor its post-marketing safety database for additional cases in the US and abroad related to heparin usage. Health care providers are encouraged to report all allergic-type reactions to any heparin infusion to FDA’s MedWatch on line at http://www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.