Baxter Healthcare Corp. Recalls All Remaining Heparin Vials and Hep-Lock Products

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials — APP Pharmaceuticals of Schaumburg, Ill. — was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxters Hep-Lock.

There have been 448 reports of adverse reactions associated with Baxters heparin product since the end of December 2007.  Fewer than 100 adverse events were recorded in all of 2007.  According to the FDA, there have also been reports of 21 deaths, four of which involve an adverse reaction to heparin.  The precise source of the heparin contamination has not yet been identified.

The FDA reported last week that it had accidentally inspected and approved the wrong Chinese pharmaceutical factory, because it had a similar name, and inadvertently granted approval to a manufacturing facility that should never have been approved. 

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

  • FDA mix-up leads allows tainted Heparin to reach the market
  • Evidence that drive-through pharmacy windows jeopardize patient safety
  • Dozens of drugs with identical or similar-sounding names pose patient safety risks

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