FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Hetero Sued for Valsartan Contamination

Nov. 19, 2018

A federal lawsuit filed in Massachusetts claims Indian generic drugmaker Hetero and its U.S. subsidiary Camber Pharmaceuticals ignored warning signs that the blood-pressure drug valsartan was contaminated and continued to supply it in the United States.

The case allegedly dates back up to six years and involves Hetero’s use of an API supplied by Chinese manufacturer Zhejiang Huahai Pharmaceuticals, which was sanctioned earlier this year by U.S. and EU authorities for supplying valsartan suspected to contain N-nitrosodimethylamine (NDMA), a possible carcinogen.

In a complaint filed in the U.S. District Court for the District of Massachusetts, plaintiff Veronica Longwell claimed the defendants willfully ignored red flags at the Zhejiang Huahai API facility and at Hetero’s Indian facilities. Introduction of the suspect products into the American market date back at least to 2015, but possibly prior to 2012, the suit alleges.

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