Heparin Recall News

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Tuesday, October 28, 2008

Heparin and the China Connection

The pharmaceutical company Baxter International was recently forced to recall Heparin.

This drug, which is used as a blood-thinner, has already gained quite a degree of infamy. It has been linked with a number of overdose cases in infants, several of which have ended in death.

The most famous of these cases involved the children of Hollywood actor Dennis Quaid. Now reports are surfacing about the conditions in which this drug was made. Sources claim that Heparin was manufactured in China, in a factory which US regulators have recently labeled as having objectionable conditions.

While the FDA is currently investigating, they are still unclear as to whether the Chinese plant is the true source of the problems or not. But perhaps more disturbing is that the FDA didn't inspect the plant at all, even before granting the approval. Why? They mixed up the company name with another one.

The FDA is currently looking into a total of 448 cases related to this troublesome drug Heparin. However, only 215 of these cases have been listed as events of interest. In order to avoid a shortage of blood-thinner in the market, APP Pharmaceuticals has increased the production in order to meet the market needs.

Baxter International seems to have landed in hot water in some other areas as well: A number of violations were found at the company's plant in Puerto Rico, including inadequate testing of irradiation equipment. Baxter has already agreed to pay a fine of $15,000.

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