Published on Friday, September 14, 2018 by Staff
The FDA announced that it has detected an additional contaminant in three lots of Torrent Pharmaceuticals recalled valsartan drugs. N-Nitrosodiethylamine (NDEA), a known animal and human carcinogen, was found in Torrent’s valsartan 160mg (Lot BV47D001) and 320mg (Lots BV48D001 and BV48D002). These tablets were produced using valsartan API, manufactured by Zhejiang Huahai Pharmaceuticals (ZHP) – also found to contain NDEA.
According to the FDA, “like NDMA [the first contaminant found in valsartan drugs], NDEA is also formed from a specific sequence of manufacturing steps and chemical reactions.” Manufacturers should continue to test their products for these contaminants. The FDA will post a testing method for the detection of NDEA that can be used by manufacturers.
Lastly, “The FDA reminds patients taking valsartan from a recalled lot to continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Any patient who is taking valsartan from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly.”
FDA Press Announcement dated Septmber 13, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620499.htm