Heparin is a widely used blood thinner used to treat and prevent blood clots. In March 2008, major recalls of heparin were announced due to severe adverse reactions and deaths from lots manufactured in a China facility that a Food and Drug Administration (FDA) investigation revealed were contaminated with OSCS. The FDA later admitted that it was lax in its responsibilities to inspect overseas drug plants before approval drugs for sale.

Though no adverse reactions have been reported to B. Braun and the manufacturer does not believe the drugs pose a significant health risk, customers who have the recalled lots heparin in their possession are urged to discontinue use immediately. B. Braun is also arranging for return of all recalled products. Customers can direct questions to B. Braun at 800-227-2863.

Patients who are or have been using this product and have experienced any problems should contact their physicians. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Heparin Recall › Tainted lots of heparin recalled

The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages.

The nightmare began in late 2007, as reports of serious allergic reactions and deaths following use of Baxter’s heparin began mounting. By March 2008, the Food and Drug Administration (FDA) issued a major recall of heparin. At the time, Baxter supplied about 50 percent of heparin to the U.S. As Baxter began pulling its heparin, investigations into the source of the contaminant focused on Baxter International’s China plant. The culprit was identified as over-sulfated chondroitin sulfate, or OSCS, a man-made chemical that mimics heparin.

While Baxter was at fault for distributing the tainted heparin, critical eyes fell on the FDA for not properly inspecting foreign drug manufacturing plants. The agency admitted it was simply too understaffed to properly inspect most of the foreign food and drug manufacturing plants. The FDA soon after received funding to open overseas field offices, the first three of which were opened in China.

The stricter inspections hardly console the victims and families of victims who suffered or died from the contaminated blood thinner. The FDA reports that as many as 395 deaths and 785 reports of serious injury were associated with the contaminated heparin.

Source: Bloomberg

SOURCE: Heparin Recall › Baxter faces numerous lawsuits over tainted heparin scandal