(Reuters) – Mylan NV said on Tuesday it would recall certain batches of blood pressure medicine valsartan in the United States after they were found to contain a probable cancer-causing impurity, the latest recall amid heightened safety concerns globally.
Shares of the company, which on Tuesday also disclosed a warning letter it received from the FDA earlier this month, fell nearly 2 percent to $ 33.91 after the bell.
The news comes a day after the European Union authorities stepped in to effectively ban sales of valsartan made by an India-based Mylan unit after some batches were found to contain the same impurity, N-nitrosodiethylamine (NDEA).
Mylan said on Tuesday it would recall at least 15 lots of medicines containing valsartan distributed in the United States between March 2017 and November 2018 and manufactured by units Mylan Pharmaceuticals and Mylan Laboratories.
Over the past year, global health authorities have been cracking down on valsartan and drugs containing the substance as an active ingredient after several batches were found to contain NDEA and a second possible carcinogen, N-nitrosodimethylamine (NDMA).
The U.S. FDA last month halted imports of drug ingredients or medicines containing ingredients produced at a factory belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals.
Huahai had recalled the tainted product from consumers in the United States in July.
Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel and Sriraj Kalluvila