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Torrent Pharmaceuticals expands voluntary recall of losartan
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Torrent Pharmaceuticals has expanded its voluntary recall of its losartan potassium tablets to include five additional lots due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, according to an FDA press release.
The expanded recall impacts three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets.
According to the FDA, the lots were found to contain NMBA in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. Specifically, Torrent is recalling all lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million, the FDA said.
According to the FDA, NMBA is a known animal and potential human carcinogen.
Torrent Pharmaceuticals was one of a half dozen drug companies that in December 2018 announced a voluntary recall of losartan potassium tablets because of trace amounts of impurities found in an active pharmaceutical ingredient. The other companies included Macleods Pharmaceuticals, Camber Pharmaceuticals, Legacy Pharmaceuticals Packaging, Teva Pharmaceuticals and Vivimed Life Sciences.
The initial announcement regarding the Torrent Pharmaceuticals recall in December 2018 was aimed at two lots. However, the company expanded the recall twice in January for a total of 16 lots. The call was expanded again in April to include 36 lots of losartan potassium tablets and 68 lots of HCTZ tablets. These previous recalls were due to the presence of N-nitrosodiethylamine in active pharmaceutical ingredients manufactured by Hetero Labs. According to a statement from Torrent Pharmaceuticals posted by the FDA at the time, the impurity has been previously classified as a probable human carcinogen by the International Agency for Research on Cancer.
Additional information can be found at the FDA website.