B. Braun Recalls More HeparinMar 24, 2008 | Parker Waichman LLP
More heparin has been recalled in the US, amid concerns that heparin ingredients imported from China have been contaminated with a counterfeit ingredient. On Friday, B. Braun Medical Inc. announced a recall of 23 lots of its blood thinner after being notified by its supplier of a nationwide recall of Heparin Sodium USP because of the contamination issue. The B. Braun action follows a similar recall of heparin sold by Baxter International that has been linked to over 700 adverse reactions, including 19 deaths.
B. Braun Medical Inc., of Irvine, California, said it was recalling the heparin lots as a precautionary measure, after Scientific Protein Laboratories said that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient it bought has a heparin-like contaminant. So far B. Braun Medical Inc. has not received any adverse event reports related to this issue.
Scientific Protein Laboratories is the same company that provided the active ingredient for Baxter International's heparin. Baxter recalled nearly all its heparin injections in the US after some patients experienced extreme allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls of Chinese-sourced heparin in Germany and Japan. Last week, the US Food and Drug Administration (FDA) confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. However, the agency has not yet determined if the chondroitin sulfate was responsible to the deaths and reactions associated with Baxter heparin.
Baxter gets some of that active ingredient from Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. The FDA said it had found contaminated crude heparin at that plant. Changzhou buys its crude heparin from two companies, called consolidators, that gather it from workshops that make it from pig intestines. Many workshops that make crude heparin are unregulated family operations. Baxter has said that its investigators have not been able to get permission from the Chinese to visit these operations, and the FDA has not yet done inspections on any of these facilities either.
While the FDA maintains that it has not yet determined if the ingredient substitution was intentional, several sources told The New York Times that it was likely not accidental. Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
Last Thursday, American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter' broader recall of heparin products. The vials were manufactured by Baxter and then placed by American Health Packaging into individually labeled bags for use in pharmacy automation equipment.