Baxter Recalls Heparin Products

Baxter International recently announced a voluntary recall of all remaining lots and doses of its heparin sodium injection multidose and single-dose vials and HEP-LOCK heparin flush products.

The FDA has received 448 reports of adverse events associated with heparin products, but some of these may be duplicate reports. In 389 of these cases, Baxter was named as the source of the product. The reports included 215 “events of interest” and 21 deaths. Most of the events occurred last year.

The FDA has launched a “far-reaching investigation” of a Chinese firm, Changzhou SPL, which made the active pharmaceutical ingredient (API) for Baxter, Michael Rogers, director of the FDA’s Division of Field Investigations, said. Two FDA inspectors were sent to China to carry out that investigation and related investigations of two “consolidators” associated with the API manufacturer. They also may inspect workshops and farms associated with the manufacture of the product, which uses pig intestines.

The agency has posted on its website a redacted version of the Form 483 observations that its investigators issued after inspecting the API plant. It can be accessed at www.fda.gov/ora/frequent/483s/Changzhouspl_heparin_20080226_483.html.

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It's the backdoor method of the Chinese trying to kill us.  Just kidding.  Seriously though this recall does affect the hospitals where I work pretty severely.  When do you think we'll stop relying on foreign countries to make a medicine that can be trusted?