Sept. 28, 2018 — The FDA on Friday moved to block all imports of drugs made with ingredients made by a Chinese plant at the center of a massive recall of heart and blood pressure medications.
The agency says Zhejiang Huahai Pharmaceuticals will be on what’s called “import alert” until it “fully determines how impurities were introduced into its API,” or active pharmaceutical ingredient, and fixes its quality systems.
“The import alert stops all API made by ZHP and finished drug products made using ZHP’s API from legally entering the United States.”
The move comes after the FDA recalled blood pressure and heart failure medicines because of the discovery of at least two potentially cancer-causing impurities.
Three lots of Torrent Pharmaceuticals’ valsartan drugs were found this month to contain NDEA, which is known to cause cancer in animals and is thought to be a human carcinogen.
Those drugs were already part of August’s recall of valsartan products for possible contamination with NDMA, another impurity that may cause cancer. More than a dozen brands of valsartan drugs are subject to the recall. For a full list, visit this FDA site.
According to the FDA, Zhejiang Huahai Pharmaceuticals discovered the NDEA in several batches of its valsartan ingredients.
European authorities in July also recalled drugs that had valsartan that were supplied by a Chinese drugmaker over concerns they may contain NDMA. More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent months.
If you take a valsartan drug for high blood pressure or heart failure, the FDA recommends you continue to take it until you can speak with your doctor or pharmacist. Even if your medication is part of the recall, the agency says continue to take it and consult your doctor for possible alternatives.
WebMD Article Reviewed by Brunilda Nazario, MD on September 28, 2018
Sources
FDA: “FDA updates on valsartan recalls,” “Valsartan products under recall — Updated August 27, 2018.”
FDA: “FDA updates on valsartan recalls,” “FDA places Zhejiang Huahai Pharmaceuticals on import alert – Updated Sept. 28, 2018.”
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