Pharmaceutical Company Connected to NDMA Impurity Placed on Import Alert
Active pharmaceutical ingredient (API) manufacturer Zhejiang Huahai Pharmaceuticals was placed on import alert on Friday, September 28 by the U.S. Food and Drug Administration (FDA). The company will determine how its products, used in valsartan-containing drug products became affected by N-nitrosodimethylamine (NDMA).
The FDA has been updating its list of valsartan products under recall, which can be found here (accurate as of September 28, 2018) (PDF).
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research when the recall was first announced.
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