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On Monday, Baxter announced they are temporarily suspending the production of the drug Heprin, after 350 negative reactions have been reported in conjunction with the drug.

The active ingredient in Heprin, a blood-thinning medication, was reportedly made at a Chinese facility that the U.S. Food and Drug Administration (FDA) failed to inspect, according to a report in the Wall Street Journal.

Baxter and the FDA both said they are unclear if the product from a Chinese supplier, is tied to allergic reactions to the drug, Heparin, which has resulted in four deaths.

An FDA spokeswoman told the Journal that the Chinese plant “was supposed to be inspected” but was not due to “human error, and inadequate information-technology systems.” The spokeswoman added that, “preparations are being made to perform an inspection as soon as possible,” according to the report.

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