Baxter Healthcare Corporation has issued multiple of Heparin recalls, after receiving reports of serious, life-threatening side effects including allergic reactions and death.
What’s the problem?
On 2/29/08, the New York Times reported that the blood thinner Heparin, might be tied to more deaths. Amid indications that more people may have died or been harmed after being given a brand of the blood thinner Heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.
According to the U.S. Food & Drug Administration, the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4.
Furthermore, the FDA has admitted that it had violated its own policy by failing to inspect SPL, the Chinese plant in question, before the factory began shipping Heparin ingredients to Baxter in 2004. China’s drug agency also did not inspect the plant.
The problems with Heparin, which is used to prevent blood clotting during dialysis and after some surgery, were first reported last month at a hospital in Missouri. Since then, the number of reported adverse reactions has risen to 448, the F.D.A. said.
Baxter Heparin Recall Timeline
- January 25, 2008 – Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials
- February 11, 2008 – Baxter’s Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
- February 28, 2008 – Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products