FRIDAY, Sept. 14, 2018 — The U.S. Food and Drug Administration warns that it has found a second impurity in three lots of Torrent Pharmaceuticals’ valsartan drug products.
The FDA first recalled valsartan medicines back in July, after the Chinese company that makes the drugs, Zhejiang Huahai Pharmaceuticals, found a contaminant called N-nitrosodimethylamine (NDMA) in several batches of its active ingredient, valsartan API.
In a news release issued yesterday, the FDA said Torrent’s valsartan 160 mg (lot BV47D001) and 320 mg (lots BV48D001 and BV48D002) tablets are also tainted with N-nitrosodiethylamine (NDEA). NDEA is classified as a known animal and suspected human carcinogen by the U.S. Environmental Protection Agency.
Contamination by both NDMA and NDEA could result from a specific sequence of manufacturing steps and chemical reactions, the FDA explained. After NDMA was detected, the agency immediately began retesting all valsartan products, including the already recalled drugs and others sold in the United States, the agency explained. The FDA’s testing shows that not all products made using Zhejiang Huahai Pharmaceuticals’ valsartan API contain the potentially dangerous impurities.
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Posted: September 2018