A pharmaceutical company is once again expanding its recall for blood pressure medications because of potential cancer-causing impurities. It's part of an ongoing string of recalls that started in July 2018.
Torrent Pharmaceuticals Limited said Thursday it would be recalling 36 more lots of Losartan potassium tablets USP and 68 more lots of Losartan potassium/hydrochlorothiazide tablets due to the detection of trace amounts of N-Methylnitrosobutyric acid (NMBA).Torrent said it was only recalling those lots in which NMBA was above the acceptable daily intake levels released by the FDA.
You can see the affected lots at this link.
The recall is the fourth expansion of one Torrent first issued in December 2018.
Patients using the recalled medication are advised to keep taking it until they can talk to their doctor about alternatives. Discontinuing use could also pose health risks.
Torrent said it has not received any reports of adverse reactions to using the medication.
The FDA said the impurities might be happening when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API (active pharmaceutical ingredients). It may also result from the reuse of materials, such as solvents. The FDA has generally stated that the cancer risk is low.