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September 23, 2019

More blood pressure medicine recalled after carcinogen found in pills

The U.S. Food and Drug Administration announced that two blood pressure drugs had trace amounts of the cancer-causing impurity NMBA

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Blood pressure medicine recalled FDA Thom Carroll/PhillyVoice

Torrent Pharma has voluntarily recalled five lots of its blood pressure medication, including Losartan Potassium and Losartan Potassium/hydrochlorothiazide after finding trace amounts of the carcinogen N-Methylnitrosobutyric acid (NMBA).

Blood pressure medicine from Torrent Pharma has been recalled for the fifth time after trace amounts of the cancer-causing impurities were found in the pills. 

Three lots of Losartan Potassium tablets and two lots of Losartan Potassium/Hydrochlorothiazide have been recalled after trace amounts of the carcinogenic NMCA – formally N-Methylnitrosobutyric acid – were found in the tablets, the U.S. Food and Drug Administration announced

Torrent Pharma recalled Losartan Potassium four other times within the past year. The drug, which is manufactured by Hetero Labs, had been recalled on Jan. 3 for after another carcinogen NDEA was found in some lots of the drug and after that on Jan. 22 for lack of sterility. It was recalled a third time in March and a fourth time in April, both instances because trace amounts of NMBA had been found in the medication. 

Earlier this month, the FDA announced it was investigating ranitidine, commonly found in Zantac, after trace amounts of NDMA was found in those pills.

The impact of ingesting these carcinogenic compounds is unclear. 

Losartan Potassium and Losartan Potassium/Hydrochlorothiazide both treat hypertension and patients with ventricular hypertrophy. Losartan Potassium also treats kidney disease in Type 2 diabetic patients. 

The following lots are the only ones being recalled by Torrent Pharma at this time. They are sorted by the product name, strength, packing count page and expiration date.

•13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E00912/31/2020
•13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E00912/31/2020
•13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D01802/28/2021
•13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D05111/30/2020
•13668-118-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.4P04D00707/31/2020

The FDA advises patients to not stop taking medication as doing so could cause more harm if a person suddenly stops without another treatment option available. Patients are advised to talk to their doctors about their medication options. 


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