Investigations

Initial Baxter Heparin Recall

In January 2008, Baxter recalled nine lots of its 1,000 unit/ml multi-dose Heparin vials after receiving over 100 reports of serious side effects and allergic reactions. Baxter also stopped manufacturing Heparin, as a part of the recall, until Baxter determines the cause of the serious side effects.

Baxter’s Heparin Recall: FDA Health Advisory

On February 11, 2008, the FDA issued a Public Health Advisory warning doctors to use Baxter Heparin only in small doses when absolutely necessary, after receiving over 350 reports of severe side effects and four deaths. The FDA further warned that doctors should carefully monitor their patients. Despite the side effects, the FDA did not require Baxter to recall all Heparin products.

Baxter Heparin Total Recall

On February 29th, Baxter recalled all Heparin products after it received reports that linked Heparin to over 400 life-threatening allergic reactions and 21 deaths. This recall covered all Baxter’s Heparin products, including small dose vials.

Baxter Studies of Contaminated Heparin following the Recall

Following the recall, Baxter and the FDA both conducted studies to determine the source of Baxter Heparin’s side effects. They concluded that the recalled Heparin supplied to Baxter from Scientific Protein Laboratories was contaminated with oversulfated chondroitin sulfate (OSCS), a supplement used to relieve arthritis. OSCS contains 5 to 20 percent of a heparin like compound, allowing the contaminated Heparin to copy the activity of Baxter Heparin and avoid detection in routine tests.

Contaminated Heparin Recalled Worldwide

Scientific Protein Laboratories received the contaminated Heparin ingredients from a Chinese facility. China is the largest heparin producer.  Germany reported over 100 allergic reactions linked to contaminated heparin received from China. Their Chinese facility, however, is not the same one that produced the contaminated heparin used by Baxter. The FDA announced that 11 different countries received contaminated heparin from China.

Medtronic Recall of Uncontaminated Heparin

Medtronic, a maker of medical devices for heart patients, recently recalled their bypass equipment including pumps, reservoirs, and blood oxygenators, that where coated with uncontaminated Heparin. Medtronic claims that this is a voluntary recall and that there is no evidence that contaminated Heparin was used on its products. 

Heparin Use after the Recall

Following the recall, the FDA recommended that doctors limit the use and dosage of Baxter Heparin and only use it if there are no medical alternatives. The FDA inspected Baxter’s New Jersey facility and the China facility for additional contaminated Heparin. Currently, the FDA is working with APP Pharmaceuticals, another FDA approved Heparin maker, to insure that there is a safe, adequate and uncontaminated supply of Heparinin the United States after the Baxter Heparin recall.

Injured by Contaminated Heparin        

To find out if you or someone you love is eligible for compensation due to exposure to contaminated Baxter Heparin that was recalled, contact us today.