Heparin Recall

In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China.[49][50] 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.[51][52] The U.S. Food and Drug Administration was quoted as stating that at least 81 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.[53] According to the New York Times: 'Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock'.

The contaminant has been identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish derived supplement often used for arthritis.[54] Since this "over-sulphated" variant is not naturally occurring and mimics the properties of heparin,the counterfeit is almost certainly intentional as opposed to an accidental lapse in manufacturing.[55] The heparin was cut from anywhere from 2-60% with a counterfeit substance due to cost effectiveness, and a shortage of suitable pigs in China.

When the FDA finally did conduct an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a letter to the Chinese company. The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin.