STORY FROM: Drugs & Medical Devices
Torrent Expands Recall of Losartan-Containing Drugs, Citing NDEA Contamination
January 23, 2019
WASHINGTON, D.C. — India-based drug maker Torrent Pharmaceuticals Ltd. has expanded its voluntary recall of losartan-containing drugs due to N-nitrosodiethylamine (NDEA) contamination.
According to the Jan. 22 press release, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).
The impurity was reportedly found in an active pharmaceutical ingredient manufactured by Hetero Labs Ltd., also based in India. Torrent is only recalling lots of losartan-containing products that contain NDEA above the acceptable daily intake ...