Both FDA and EMA have issued recalls.
The common blood-pressure medication valsartan supplied by Chinese manufacturer Zhejiang Huahai Pharmaceutical (ZHP) is now subject to recalls in both the US and Europe. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have issued voluntary recalls of some drugs containing valsartan manufactured by ZHP due to the potential risk for cancer resulting from contamination of the active pharmaceutical ingredient (API) with N-nitrosodimethylamine (NDMA). NDMA is classified by the World Health Organization’s International Agency for Research on Cancer as a probable carcinogen to humans.
In the US, recalled products include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco. None of branded drug maker, Novartis’ products marketed in the US are recalled, according to the company.
In Europe, however, Novartis is recalling Sandoz’ valsartan and valsartan HCT film-coated tablets in 23 countries. Other companies affected by the EU recalls include Teva, Stada, Dexcel Pharma and Accord Healthcare. Several companies are also recalling valsartan products formulated with the Huahai’s API in other countries, including Japan, Canada, China, Hong Kong and Taiwan.
Hiahai suspended production and informed the regulatory agencies after discovering the contamination. The company believes the problem arose after it implemented a new manufacturing process. FDA is working with the company to solve the problem and prevent the issue from recurring. It is also investigating the level of NDMA in the recalled products to determine the potential effect on patients and working to ensure an adequate supply of alternative medications.