(This 28 September story has been refilled as FDA spokesman corrects information to show import ban only applies to a single Huahai factory)
NEW YORK (Reuters) – The U.S. Food and Drug Administration said on Friday that it will no longer allow imports of drug ingredients or drugs made with ingredients produced at China’s Zhejiang Huahai Pharmaceuticals’ Chuannan factory, after a recall of one of its drugs that contained a probable carcinogen.
The Chinese bulk manufacturer of the common blood and heart drug valsartan recalled the product from consumers in the United States in July, because an impurity linked to cancer had been detected.
On Sept. 28, the FDA posted a statement on its website that said: “The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States.”
On Oct. 10, FDA spokesman Jeremy Kahn said that the statement is incorrect, and the import ban only applies to the Chuannan factory. As of Oct. 10, the incorrect statement was still on the FDA’s website.
(Reporting by Michael Erman; Editing by Chizu Nomiyama)