A pharmaceutical company has expanded the recall of its blood pressure medications, the latest development in a long list of recalls that have been happening for the past 14 months.
Torrent Pharmaceuticals toldTrusted Source the Food and Drug Administration (FDA) late last week that it was expanding its recall to three additional lots of Losartan potassium tablets and two additional lots of Losartan potassium/hydrochlorothiazide tablets.
Company officials said an impurity suspected of being a cancer-causing agent had been found in the finished manufactured version of the tablets.
All these recalls are due to the detection in the products of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which has been classified as a potential cancer-causing substance. The latest action is the fifth recall since December of blood pressure medications manufactured by Torrent Pharmaceuticals. The announcement is also the latest in a string of actions involving blood pressure medications since the first batch was recalled in July 2018. In June, an online pharmacy has filed a petition with the Food and Drug Administration, saying they have found another cancer-causing chemical in blood pressure medications that have been recalled.
According to CBS News, Valisure officials told the FDA the chemical dimethylformamide (DMF) is present in the common medication valsartan.
An FDA official told CBS the agency will investigate Valisure’s claim.
An official at Novartis, which manufactures a brand name version of valsartan, told CBS it does not use DMF in its medications.
The week before, a large pharmaceutical firm had expanded its recent recall of blood pressure medications due to concerns over a cancer-causing agent.
Officials at Teva Pharmaceuticals announcedTrusted Source that the company is recalling six more lots of its losartan potassium tablets. Four of the lots are 100mg strength while two are 50mg strength.
The pills were sold exclusively to Golden State Medical Supply Inc., which packaged the medications under its own label and sold them in bottles containing 30, 90, and 1,000 tablets. In April, Teva announcedTrusted Source it has initiated a voluntary recall of 35 lots of losartan potassium USP tablets. Of those, 29 lots were 100mg strength while six lots were 25mg strength. Company officials said the recall was due to the detection of an impurity of an active pharmaceutical ingredient.
The week before, Torrent Pharmaceuticals Limited toldTrusted Source the FDA it was recalling an additional 36 lots of its losartan potassium tablets USP and an additional 68 lots of losartan potassium/hydrochlorothiazide tablets USP.