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China Provincial FDA Probes Drug Maker Over Herbal Injectable

This article was originally published in PharmAsia News

Executive Summary

A Chinese provincial FDA is investigating drug maker Xi'an Jiahui Pharmaceutical over its injectable herbal drug for chronic renal failure. The Shaanxi Province FDA said the company has voluntarily closed its facilities while the probe continues into chills and high fever reported in 23 patients given the drug at a hospital. Two batches of the drug came up positive in a pyrogen reaction test, but an initial investigation suggests the drug maker's production did not violate any laws and that technical problems may have been involved. The two batches were recalled. (Click here for more
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