Baxter Heparin recall expanded

By Harvey Kirk
Posted February 29, 2008

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A partial Baxter Heparin recall first issued last month, has now been expanded to include all forms of the blood thinner manufactured by Baxter International, Inc. which contain ingredients produced at one plant in China. There have been hundreds of reports of severe Baxter heparin allergic reactions, resulting in serious and potentially fatal injuries. The lawyers at Saiontz & Kirk, P.A. are reviewing Heparin lawsuits throughout the United States.

>>PRIOR POST (1/22/2008): Heparin Recall due to risk of Allergic Reactions

On January 17, a nationwide Baxter Heparin recall was issued for nine lots of their multi-dose vials of blood thinner, which are primarily used during dialysis treatment or cardiac surgery. As the number of reported problems associated with heparin continued to grow, production was halted by Baxter earlier this month and the recall has now been expanded to include practically all heparin sold by the company.

This week, the FDA released an inspection report which found quality control and manufacturing problems at a Chinese plant where the active ingredient in most Baxter Heparin is made. In addition, the latest adverse event figures indicate that the FDA has received nearly 450 reports of heparin allergic reactions, including 21 deaths, which may be related to the recalled Baxter heparin.

>>PRIOR POST (2/14/2008): Baxter Heparin Problems lead to halt in production

While it remains unclear whether the deficiencies found at the plant in China are directly responsible for the Baxter Heparin problems, a substantially redacted inspection report from the FDA indicates that some of the severe quality control lapses included:

• Failing to maintain procedures outlining removal of impurities in the raw materials
• Incidents where heparin which did not meet specifications was reprocessed without determining what caused the problems
• Lack of records indicating the source of the suppliers’ product
• Improperly cleaned and maintained equipment.

The Baxter Heparin recall now applies to all multidose vials, singledose vials and Baxter HEP-LOCK, which is a heparin solution used to flush out intravenous lines. The full recall was delayed for several weeks to allow additional time for other heparin makers to increase the supply of the blood thinner and avoid a shortage of the critical drug.

The complete list of recalled products include:

• Baxter heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials
• Baxter heparin sodium injection 5000 units/mL 10mL multi-dose vials
• Baxter heparin sodium injection 10,000 units/mL 4mL multi-dose vials
• Baxter heparin sodium inecction 1000 USP units/mL, 5000 USP units/mL and 10,000 USP units/mL single-dose vials
• Baxter HEP-LOCK and Baxter HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative free.

BAXTER HEPARIN RECALL LAWSUITS

The reported Baxter Heparin allergic reactions have included problems such as:

• Stomach Pain or Discomfort
• Nausea, Vomitting or Diarrhea
• Difficulty Breathing, Increased Heart Rate, Dizziness or Fainting
• Decreased or Low Blood Pressure
• Shock
• Death

If you, a friend or family member suffered a severe allergic-type Heparin reaction after receiving the blood thinner, the problems may have been caused by one of the recalled products. To determine if financial compensation may be available, request a free consultation and Baxter heparin lawsuit evaluation.