FDA Issues Warning Letter to Zhejiang Huahai in Valsartan Recall

   By Colin Kellaher 
 

The U.S. Food and Drug Administration on Wednesday said it issued a warning letter to Zhejiang Huahai Pharmaceutical Co. (600521.SH), which made the active pharmaceutical ingredient involved in the recall of the blood-pressure drug valsartan.

The agency said the letter outlines several manufacturing violations at the company's plant in Chuannan, China, including impurity control, change control and cross contamination from one manufacturing process line to another.

Several drug makers, including Mylan N.V. (MYL), Teva Pharmaceutical Industries Ltd. (TEVA) and Torrent Pharmaceuticals Ltd. (500420.BY), have recalled drugs containing the ingredient due to the detection of trace amounts of a potentially cancer-causing impurity.

The recalls of valsartan, found in commonly prescribed heart medicines, began in July due to the presence of N-nitrosodimethylamine, a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen.

The FDA, which noted that it is still looking into the root cause of the impurity, said the violations at Zhejiang Huahai's plant "reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk."

The agency put the plant on import alert in September, stopping all active pharmaceutical ingredients made there and finished drug products made using the ingredients from legally entering the U.S. The FDA said it may withhold approval of any new applications or supplements listing Zhejiang Huahai as a drug manufacturer until the violations are corrected.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

December 12, 2018 10:18 ET (15:18 GMT)

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