FDA Issues Border Alert for All Heparin Products

The FDA is putting into effect a border alert for all heparin products manufactured by the Changzhou SPL plant, Baxter's supplier of heparin API. This alert would stop all heparin products produced by Changzhou SPL that are slated for entry into the US now and in the future.

The FDA is putting into effect a border alert for all heparin products manufactured by the Changzhou SPL (Changzhou, China) plant, Baxter Healthcare’s (Deerfield, IL) supplier of heparin active pharmaceutical ingredient (API). This alert would stop all heparin products produced by Changzhou SPL that are slated for entry into the US now and in the future.

In a media conference call on March 14, 2008, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that an import bulletin has also been issued that alerts FDA investigators to consider all heparin products “products of interest” and will force all manufacturers of heparin products to test them for contaminants.

Several manufacturers have already agreed to test their API for contamination. Products found to be contaminated will be detained by the FDA for further testing. In doing this, the FDA hopes to be able to trace the origins of the contamination.

Woodcock also stated that out of the 28 samples tested from the Changzhou plant, 20 were contaminated with the heparin-like compound.

Woodcock said in a March 5 media conference call that, after advanced testing, the FDA identified a “heparin-like” substance in concentrations making up 5 to 20% of the APIs that were tested. She said that the substance reacted in a way that was similar to heparin, which is why it was not detected earlier. There was no direct link yet made between the contaminant and the recent reports of severe adverse reactions to the drug.

The FDA has received reports of 46 deaths of people who have used heparin products, and 785 adverse reactions to heparin products. They have confirmed that 19 of the deaths and 350 of the severe reactions are related to the drug.

The API for Baxter’s recalled heparin products are produced by Scientific Protein Laboratories’ (SPL, Waunakee, WI) manufacturing sites in Wisconsin and Changzhou, China. On February 29, 2008, Baxter recalled multi-dose vials, single-dose vials, and HEP-LOCK heparin flush products, which all contain the API that is produced by the Changzhou SPL plant.

On March 6, 2008, German authorities initiated a precautionary recall of heparin products after receiving reports of adverse reactions that were similar to those reported to the FDA.

For more information on the heparin situation, see BioPharm’s previous news coverage.

German Ministry of Health Recalls Heparin Products

FDA Finds "Heparin-like" Contaminant in Heparin API

Baxter Expands Heparin Recall, FDA Issues 483 to China Facility

Letters Sent to Baxter and FDA Request Answers on Heparin Situation

For charts outlining the FDA’s role in the heparin situation, see the

Heparin Update

section of the FDA web site.