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30 November 2018

When a suspected carcinogen was detected by a U.S. drugmaker last summer in the API it had acquired to make blood pressure drugs, it first appeared to be another issue of tainted products produced in China. Since then, the FDA has learned the problem is much broader, with two of the largest generics drugmakers now recalling dozens of lots after Mylan found a suspected carcinogen in the API it produced.

Mylan last week announced it had found that an API it manufactured at one of its plants in India was tainted with N-nitrosodiethylamine (NDEA), one of two probable carcinogens the FDA has been tracking. It recalled 15 lots of selected valsartan products, including seven lots of valsartan tablets, six lots of amlodipine and valsartan combo tablets, and two lots of valsartan and hydrochlorothiazide combo tablets.

This week, Teva Pharmaceuticals said it is recalling to the patient level all lots, 49 in all, of its valsartan products in the U.S. because they had been made with the Mylan API. They include its amlodipine and valsartan combination tablets and amlodipine, valsartan and hydrochlorothiazide combination tablets.

The global recall of valsartan-made drugs began this summer when the FDA and EU learned that the valsartan API made by China’s Zhejiang Huahai Pharmaceuticals contained potential carcinogens NDEA and N-nitrosodimethylamine (NDMA). When regulators delved further they learned about how certain manufacturing steps taken under certain conditions created trace amounts of the impurities, something they were not aware of.

The FDA banned APIs coming out of Huahai’s manufacturing site in Chuannan. The FDA lambasted the company in an 11-observation Form 483 for making manufacturing process changes without conducting proper risk assessments.

Since then the FDA and EU regulators have expanded the investigation into other “sartan” products and have found impurities in the irbesartan API produced by India’s Aurobindo and in losartan products made using API from Huahai.

The FDA says there is very little risk of the impurities causing problems and no adverse reactions have been seen. Still, they continue to ask drugmakers to pull their products off the market when impurities are detected. There are still lots of blood pressure medications that have been unaffected by the recalls, according to a list (PDF) maintained by the agency.