WASHINGTON, D.C. — The U.S. Food and Drug Administration announced a safety recall for losartan potassium and losartan potassium/hydrochlorothiazide issued by the company that manufactures the drug Torrent Pharmaceuticals, Limited. Torrent Pharmaceuticals, Ltd. voluntarily issued the recall warning, and the FDA posted notice of the recall as a public service. The FDA did not order the recall. According to the FDA, the recall concerns an impurity, albeit at trace amounts, found in the active ingredient in the losartan line of products which is manufactured by another company called Hetero Labs, Limited.
Torrent Pharmaceutical, Ltd. expanded its most recent recall campaign to include 104 additional lots of the losartan-based medication. Out of the 104 lots of medicine, 36 lots containing Lorsatan potassium were recalled. The remaining lots were for losartan potassium/hydrochlorothiazide. The impurity that was detected in the active ingredient in losartan is called N-Methylnitrosobutyric acid and identified by the abbreviation NMBA. Torrent identified and recalled the lots that contain NMBA above the levels permitted by the FDA.
To date, Torrent Pharmaceuticals, Ltd. has not received any notifications of adverse events caused by the excessive levels of NMBA in the medications. However, Torrent Pharmaceuticals, Ltd. and the FDA remind consumers that they must notify their physicians immediately if they experience unexpected side effects from taking losartan or fall ill after taking their prescription. The FDA advises patients not to discontinue using their prescription medications until first consulting their treating physicians.
Torrent Pharmaceuticals, Ltd. distributed its losartan products throughout the U.S. via the company’s wholesale distributor and has taken steps to notify its retail customers in writing and via telephonic message to inform them that the lots should be returned. Torrent’s wholesale distributor was instructed to contact its customers to convey the urgency of the recall and to follow the recall instructions to return the contaminated medication immediately.
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