FDA halts imports from China’s Huahai after heart drug recall

NEW YORK (Reuters) – The U.S. Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by China’s Zhejiang Huahai Pharmaceuticals, after a recall of one of its drugs that contained a probable carcinogen.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed/File Photo

The Chinese bulk manufacturer of the high blood pressure treatment valsartan recalled the product from consumers in the United States in July, because an impurity linked to cancer had been detected.

The FDA said it was halting imports after it found major manufacturing process issues during a more recent inspection of Huahai’s plant. The agency said the freeze on the imports would remain in place until the Chinese manufacturer determines how the impurities were introduced and improves its quality control systems.

In a letter to Huahai posted on the FDA’s website on Sept. 20, the regulator pointed out a range of serious problems, including with the company’s quality management system, how it evaluates the impact of changes to its manufacturing process, and its handling of products with impurities.

Reporting by Michael Erman and Alexandra Harney in Shanghai; Editing by Chizu Nomiyama and Bill Berkrot

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