FDA warning for API manufacturer involved in valsartan recall

12 December 2018

The US Food and Drug Administration (FDA) has sent a warning letter to China-based Zhejiang Huahai Pharmaceutical (ZHP), the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an FDA investigation into probable cancer-causing impurities in certain commonly-prescribed heart medicines.

Manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination are raised in the letter.

Valsartan is a drug in the angiotensin II receptor blocker (ARB) class used to treat high blood pressure and heart failure.

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