FDA proposes limits on nitrosamine impurities, Torrent recalls losartan made with Hetero's API

FDA proposes limits on nitrosamine impurities; Torrent recalls losartan made with Hetero’s API

By PharmaCompass

2018-12-27

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Last month, Sandoz Inc had issued a voluntary recall of one lot of losartan potassium and hydrochlorothiazide due to the detection of trace amounts of NDEA (N-Nitrosodiethylamine) impurity found in the API which was manufactured by Zhejiang Huahai Pharmaceutical Co Limited.

And last week, there was news that Torrent Pharmaceuticals Limited too is voluntarily recalling two lots of losartan potassium tablets to the consumer level due to the detection of trace amounts of the same impurity — NDEA — in its API manufactured by Hetero Labs Limited.

To date, Torrent Pharmaceuticals has not received any reports of adverse events related to this recall, FDA said.

Losartan is used in the treatment of hypertension and hypertensive patients with left ventricular hypertrophy. It is also used to treat nephropathy in type 2 diabetes.

Meanwhile, the agency has also published interim acceptable intake levels of nitrosamine impurities in angiotensin II receptor blockers (ARBs) for manufacturers to use. This should help ensure their finished drug products are safe for patients.

The agency evaluated safety data for N-Nitrosodimethylamine (NDMA) and NDEA to determine an interim acceptable intake level for these impurities.

The agency will use the interim limits to recommend manufacturers to conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in their finished drug product.

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