Heparin Recall: Are You or Your Patients at Risk?

Heparin is a blood thinner manufactured by Baxter Healthcare. On February 11, the FDA announced that Baxter Healthcare temporarily stopped making multiple dose vials of heparin (the kind that gets injected) because of recent deaths and diminished quality of life threatening reactions such as difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure which can lead to shock.

Since late December 2007, the FDA and Baxter Healthcare have received around 350 adverse event reports with approximately 40 percent have been characterized as serious cases. Most of the cases happened at kidney dialysis centers. Other cases included patients undergoing heart surgery or a specialized blood cell treatment called photopheresis.
The FDA is conducting an ongoing investigation of Baxter Healthcare’s heparin production but so far, no source has yet been identified.

Baxter Healthcare will continue making single-dose vials of heparin but don’t take single doses and combine into larger, higher doses.  Note to healthcare providers: Serious adverse events of the same type have been reported in a few cases where single-dose vials of Baxter heparin were combined in order to give a larger, higher dose to patients. Adverse reactions are related to larger dosing, and therefore even using single-dose vials to generate the dose necessary could be problematic.

The temporary manufacturing suspension applies only to multiple-dose vials of heparin produced by Baxter Healthcare. The suspension does not apply to other heparin makers or to Baxter Healthcare’s single-dose vials of heparin unless combined into larger, higher doses.

The affected batches are…

NDC numbers: 0641-2440-45, 0641-2440-41, 0641-2450-45, 0641-2450-41.

Lots: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111.

Baxter Healthcare notified doctors and hospitals and doctors and hospitals should have notified patients who have been treated with multiple dose vials of injected heparin. If you or a loved one have been injected with multiple dose vials of heparin or a combination of single dose vials at kidney dialysis centers or while undergoing heart surgery or a specialized blood cell treatment called photopheresis and are the victim of serious heparin side effects – please do not hesitate to contact the Pennsylvania personal injury law firm, Monheit Law.

You are at risk and you should be aware of your legal options.