Torrent Pharma Expands Recall Of BP Drug Losartan For Cancer Risk

Torrent Pharma Expands Recall Of BP Drug Losartan For Cancer Risk

September 23, 2019

Torrent Pharmaceuticals Limited expanded the recall for many batches of high blood pressure drug Losartan Potassium, citing potential cancer risk.

The U.S. Food and Drug Administration said the recall involved an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium / hydrochlorothiazide tablets, USP.

Torrent noted that trace amounts of N-Methylnitrosobutyric acid or NMBA, a probable carcinogen, was detected while testing the finished products. The company is only recalling lots of losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA.

The affected products were manufactured utilizing active pharmaceutical ingredient or API manufactured by Hetero Labs Limited.

The tablets were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers.

The company urged the patients who are taking Losartan Potassium to continue the medication and also to contact their pharmacist or physician.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.

Torrent had earlier recalled several lots of Losartan for containing another carcinogen N-nitrosodiethylamine or NDEA.

In the past, many drug companies have recalled hundreds of lots of the blood pressure and heart medications valsartan, losartan and irbesartan after tests found that the drugs had trace amounts of carcinogens.

Macleods Pharmaceuticals Limited in June had recalled 32 lots of Losartan due to the presence of NMBA. Losartan ingredient manufacturer Hetero Labs was also linked to the recall.

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