Torrent Recalls More Tainted Losartan

Megan Brooks

September 23, 2019

Torrent Pharmaceuticals Limited is once again expanding its voluntary recall of contaminated sartans to include three more lots of losartan potassium and two more lots of losartan-hydrochlorothiazide combination tablets.

The nationwide recall, to the consumer level, is due to the detection of trace amounts of the potential carcinogen N-Methylnitrosobutyric acid (NMBA) above acceptable daily intake levels set by the US Food and Drug Administration (FDA). The impurity was detected in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Details on the products and lots are available in the September 19 recall notice on the FDA website.

The recalled medications were distributed nationwide to Torrent's wholesale distributor, repackager, and retail customers. The company is notifying its distributors and customers by phone and with a recall letter to immediately stop distribution of the recalled lots and to notify their subaccounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

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

This is the fifth expanded recall for the company, after it first announced the recall of two lots of losartan potassium tablets December 20, 2018 because of the presence of the probable carcinogen N-Nitrosodiethylamine (NDEA) in the API manufactured by Hetero Labs.

On April 18, Torrent announced an expanded recall to include 36 more lots of losartan potassium and 68 more lots of losartan–hydrochlorothiazide combination tablets.

The recall was expanded to include eight additional lots of losartan on January 3 and six lots losartan and losartan–hydrochlorothiazide tablets on January 22 — both due to unacceptable levels of NDEA.

On March 1, it was further expanded to include 60 lots of losartan and 54 lots of losartan–hydrochlorothiazide tablets due to unacceptable levels of NMBA.

The FDA keeps an updated list of recalled angiotensin receptor blockers (ARBs).

In April, the agency published a list of 40 ARBs it had determined were free of contamination from nitrosamines, as reported by Medscape Medical News.

Last week, drug regulators in the United States and Europe announced they are investigating medicines that contain ranitidine (multiple brands) for the presence of NDMA.


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