Heparin Recall History
The FDA began recalling Heparin in January 2008 amid concerns that contaminated Heparin had entered the US
In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA admitted that it had violated its own policies by failing to inspect the American pharmaceutical firm Scientific Protein’s plant in China before approving the drug for sale.
The U.S. Food and Drug Administration was quoted as stating that at least 395 deaths were believed linked to a raw heparin ingredient imported from the People’s Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use.
- Problems with the contaminated heparin included:
- Difficulty breathing
- Excessive sweating
- Rapidly falling blood pressure that led to life-threatening shock
Since January 2008, there have been 6 major recalls of contaminated heparin.
- January 25, 2008 – Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials (pdf)
- February 28, 2008 – Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (pdf)
- March 20, 2008 – American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall (pdf)
- March 21, 2008 – B. Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (pdf)
- March 28, 2008 – Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin (pdf)
- May 7, 2008 – Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (pdf)
Do you have a Heparin claim?
If you or your loved one has suffered a serious injury or death as a result of contaminated heparin, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.