Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

PUBLISHED: Jan 23, 2019
Relevant to: All Healthcare Organizations

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide 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. Torrent is only recalling lots of losartan containing products that contain Nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

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

Patients who are on losartan potassium and hydrocholothiazide tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

The products subject to recall are listed in the recall notice, link below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Follow the link below for additional information.

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