Macleods Pharm Recalls 1 Lot of Hypertension Drug

Macleods Pharmaceuticals has recalled one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern. The recall is due to unacceptable amounts of N-nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Last month, an updated FDA drug safety alert about the safety of some generic versions of angiotensin II receptor blocker medicines that contain nitrosamine impurities (N-Nitrosodimethylamine and NDEA), which are probable human carcinogens, has now dismissed significant safety concerns. “We were deeply concerned when we learned about the presence of these impurities,” the alert says. “We immediately undertook a major operation to investigate and to identify the root causes for the presence of these impurities in some ARB drugs, and to work with companies to address the risks that the impurities pose to patients.”