Torrent Expands Recall of Losartan Drugs, Citing NMBA Contamination

WASHINGTON, D.C. — India-based drug maker Torrent Pharmaceuticals Ltd. has further expanded its voluntary recall of losartan-containing drugs to include 114 additional lots due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA), according to the Food and Drug Administration.

A March 4 FDA alert says NMBA, a potential human carcinogen, was reportedly found in an active pharmaceutical ingredient manufactured by Hetero Labs Ltd., also based in India.

Torrent and Hetero are only recalling lots of losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million, the FDA says.

The agency emphasized that drugs containing only amlodipine …