Friday, December 21, 2018

Torrent Pharmaceuticals Limited Recalls Losartan potassium tablets Due To N-nitrosodiethylamine (NDEA) API Presesnce.

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
“Product Labeling of Losartan Potassium Tablet, USP 100 mg, 90 tablets”Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which 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 as per International Agency for Research on Cancer (IARC) classification.

More info at Recalls Global

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